BIOSYNEX STREPTATEST
Report
- Report Number
- 3005641941-2023-00001
- Event Type
- Death
- Date Received
- January 19, 2023
- Date of Event
- December 17, 2022
- Report Date
- March 30, 2023
- Manufacturer
- ABON BIOPHARM (HANGZHOU) CO., LTD.
- Product Code
- GTY
- PMA / PMN Number
- K010582
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- 003
Narratives
ON THE 16TH JANUARY THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED FOR THE INITIAL REPORT. THE PATIENT ARRIVED AT THE EMERGENCY DEPARTMENT WITH CIRCULATORY DEFICIENCY. THE CHILD HAD A BLOTCHY SKIN, WITH DISCOLORATION TIME OF 8 SECONDS. THE PATIENT WAS GIVEN SODIUM CHLORIDE, NACL, AND CRYSTALLOIDS FLUID BY THE INTRAOSTEAL ROUTE. PATIENT DIED AFTER 30 MINUTES OF CARDIO-PULMONARY RESUSCITATION. A RAPID TEST WAS PERFORMED ON FLUID FROM PLEURAL PUNCTURING. THE RESULT OF THE TEST WAS POSITIVE. AUTOPSY TO BE PERFORMED. ALSO, SEVERAL CASES OF SCARLET FEVER WERE REPORTED IN THE SCHOOL IN WHICH THE CHILD ATTENDED. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED. DUE TO INSUFFICIENT INFORMATION PROVIDED UNABLE TO IDENTIFY ANY MISUSE OR DEVIATION AGAINST THE PACKAGE INSERT. NO IMAGES WERE PROVIDED BY THE CUSTOMER FOR REVIEW. THE BATCH RECORD OF STA2062002 WAS REVIEWED, THE QUALITY CONTROL RELEASE DATA MET ALL SPECIFICATIONS. THE RETAIN PRODUCT TESTING WAS PERFORMED ON LOT STA2062002. ALL RETAINED DEVICES SHOWED EXPECTED POSITIVE RESULTS ON POSITIVE SAMPLES. FALSE NEGATIVE RESULTS WERE NOT OBSERVED. THE COMPLAINT INVESTIGATION PROVIDED INSUFFICIENT OBJECTIVE EVIDENCE TO DETERMINE THE MOST PROBABLE CAUSE. NO PRODUCT DEFICIENCY WAS IDENTIFIED DURING THIS INVESTIGATION. THE INVESTIGATION SHOWED THE DEVICE FUNCTIONED CORRECTLY. THIS COMPLAINT WAS ESCALATED TO THE QUALITY MANAGEMENT TEAM. BASED ON THE ABOVE CONCLUSION NO FURTHER ESCALATION OR CORRECTIVE ACTION IS REQUIRED AT THIS TIME. WE WILL CONTINUE TO MONITOR FOR THESE COMPLAINT TYPES. DEVICE NOT AVAILABLE. SINGLE USE.
ADDITIONAL INFORMATION ON THE COMPLAINT EVENT HAS BEEN RECEIVED FROM THE INITIAL REPORTER. WE ARE CURRENTLY CONDUCTING AN UPDATED INVESTIGATION AND A SUPPLEMENTAL MDR CONTAINING THE UPDATED INFORMATION WILL BE FILED WITH THE FDA UPON COMPLETION OF THE INVESTIGATION. DEVICE NOT AVAILABLE. SINGLE USE
WE ARE CURRENTLY CONDUCTING AN UPDATED INVESTIGATION AND A SUPPLEMENTAL MDR CONTAINING THE UPDATED INFORMATION WILL BE FILED WITH THE FDA UPON COMPLETION OF THE INVESTIGATION. CORRECTED (PROCODE) GTY. DEVICE NOT AVAILABLE. SINGLE USE
THE MDR WAS INITIALLY FILED BASED ON A COMPLAINT RECEIVED FROM BIOSYNEX S.A., A MANUFACTURER BASED IN FRANCE, WHO PURCHASE THE PRODUCT FROM THE SUPPLIER (ABON (HANGZHOU) BIOPHARM CO., LTD), AND COMMERCIALIZE THE PRODUCT IN AN OWN-LABEL BASIS. THE POUCHED STRIPS CONTAINED IN THE BIOSYNEX STREPTATEST ARE MANUFACTURED BY ABON BIOPHARM, AND THEN SHIPPED TO BIOSYNEX S.A. FOR FURTHER PACKAGING INTO KIT AND INCLUSION OF THE BIOSYNEX S.A. INSTRUCTIONS FOR USE (IFU). ABON BIOPHARM FILED THE ABOVE MDR AS THE DEVICES IN THE BIOSYNEX STREPTATEST TEST KIT ARE SAME/SIMILAR TO THE STREP A RAPID TEST STRIP MARKETED IN THE US UNDER 510(K) K010582. INITIAL COMPLAINT FROM CUSTOMER WAS MADE TO BIOSYNEX VIA ANSM (THE FRENCH NATIONAL AGENCY FOR MEDICINES AND HEALTH PRODUCT SAFETY). BIOSYNEX HAVE NOT BEEN MADE AWARE OF THE CUSTOMER NAME AND ONLY RECEIVED LIMITED INFORMATION FROM ANSM. BIOSYNEX REQUESTED CUSTOMER DETAILS AND FURTHER INFORMATION FROM ANSM HOWEVER THIS DETAIL HAS NOT BEEN SHARED TO DATE. PLEASE SEE BELOW FOR A SUMMARY OF INVESTIGATION CONDUCTED AND CONCLUSION: RETAIN TESTING PRODUCT TESTING WAS PERFORMED ON LOT STA2062002; 10 PIECES FROM THIS LOT OF RETAINED DEVICES WERE TESTED WITH QC POSITIVE SAMPLES ACCORDING TO PROCEDURE, AND RESULTS WERE READ AT 5 MINUTES PER THE IFU (INSTRUCTION FOR USE). ALL RETAINED DEVICES TESTED SHOWED EXPECTED POSITIVE RESULTS USING POSITIVE SAMPLES. FALSE NEGATIVE RESULTS WERE NOT OBSERVED AND NO PRODUCT DEFICIENCY IDENTIFIED AND THE ALLEGED FALSE NEGATIVE WAS NOT REPLICATED. MANUFACTURING BATCH RECORDS FOR LOT STA2062002 WAS REVIEWED AND CONFIRMED THERE WERE NO NON-CONFORMANCES OR MANUFACTURING DEVIATIONS FOR THIS LOT AND THE QUALITY CONTROL (QC) RELEASE DATA MET QC SPECIFICATION. A REVIEW OF THE INSTRUCTIONS FOR USE FOR BIOSYNEX STREPTATEST WAS CONDUCTED AND NOTED THAT THE IFU CONTAINS THE FOLLOWING INFORMATION IN RELATION TO NEGATIVE TEST RESULTS: - A NEW SAMPLE MUST BE COLLECTED AND TESTED BY TRADITIONAL CULTURE METHODS IF A GROUP A STREPTOCOCCUS INFECTION IS SUSPECTED DESPITE A NEGATIVE RESULT. - AS FOR ANY IN-VITRO DIAGNOSTIC, THE CLINICAL DIAGNOSIS SHOULD NOT BE BASED ON THE SOLE TEST RESULT BUT SHOULD BE MADE BY THE CLINICIAN AFTER ALL CLINICAL AND LABORATORY EVALUATIONS HAVE BEEN COMPLETED. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED. DUE TO INSUFFICIENT INFORMATION BEING PROVIDED IT WAS NOT POSSIBLE TO CONFIRM IF THE IFU WAS ADHERED TO OR TO IDENTIFY IF THERE WAS ANY MISUSE OF DEVICE OR DEVIATION FROM THE PACKAGE INSERT. FROM THE INFORMATION THAT WAS PROVIDED BY THE CUSTOMER IT CANNOT BE CONFIRMED IF A NEW PATIENT SAMPLE WAS TESTED VIA A CULTURE METHOD. ANSM REQUESTED SAMPLES FROM LOT STA2062002 TO BE PROVIDED FOR EVALUATION. BIOSYNEX PROVIDED SAMPLES TO ANSM FOR EVALUATION AND NO FURTHER CORRESPONDENCE HAS BEEN RECEIVED FROM ANSM. THE RISK MANAGEMENT REPORT (B)(4) WAS REVIEWED AND FALSE NEGATIVE RESULTS ASSESSED FOR THIS PRODUCT IST-501 SHOWED NO NEW HAZARD WAS IDENTIFIED. THE COMPLAINT HISTORY DATA FOR PRODUCT STREP A RAPID TEST STRIP HAS BEEN REVIEWED. IN THE PREVIOUS TWO YEARS (01JAN 2021 TO 31 DEC 2022), 30 FALSE NEGATIVE COMPLAINTS HAVE BEEN RECEIVED, WITH THE EXCEPTION OF THIS COMPLAINT, THERE WAS ONE OTHER COMPLAINT WHICH MENTIONED DEATH OR SERIOUS INJURY (MDR 3005641941-2022-00007). COMPLAINTS WILL CONTINUE TO BE MONITORED AND TRACKED. DESPITE MULTIPLE ATTEMPTS TO OBTAIN MORE INFORMATION, NO ADDITIONAL INFORMATION HAS BEEN OBTAINED. BASED ON ABOVE INFORMATION THERE HAVE BEEN NO DEVICE DEFICIENCY IDENTIFIED AND THE INVESTIGATION IS DEEMED COMPLETE. SHOULD ANY FURTHER FEEDBACK BE RECEIVED FROM ANSM, ABON BIOPHARM HANGZHOU CO. LTD WILL FILE A SUPPLEMENTAL REPORT WITH THE FINDINGS.DEVICE NOT AVAILABLE. SINGLE USE.
A COMPLAINT WAS RECEIVED BY BIOSYNEX S.A., BASED IN FRANCE, WHO IS A 3RD PARTY MANUFACTURER OF STREP A RAPID TEST STRIP KITS. THE TEST DEVICE CONTAINED IN BIOSYNEX'S KIT IS MANUFACTURED BY ABON BIOPHARM, HANGZHOU, CO., LTD. THIS MDR IS BEING SUBMITTED BY THE DEVICE PRODUCT MANUFACTURER ABON BIOPHARM, HANGZHOU, CO., LTD AS THE DEVICE IN THE TEST KIT IS SAME/SIMILAR TO STREP A PRODUCT CATALOG, IST-501D, THAT IS MARKETED IN THE US. ON THE (B)(6) 2022, BIOSYNEX S.A., 3RD PARTY MANUFACTURER, EMAILED TECHNICAL SUPPORT TO REPORT A NOTIFICATION FROM ANSM OF THE DEATH OF A 6 YEAR OLD PATIENT ON (B)(6) 2022 FOLLOWING STREP A MENINGITIS WHERE A NEGATIVE RESULT WAS OBTAINED ON THE (B)(6) 2022 USING STREP A RAPID TEST STRIP, PART NUMBER: IST-501, LOT NUMBER STA2062002. AN ANTIBIOTIC WAS NOT ADMINISTERED TO THE PATIENT ON (B)(6) 2022 BASED ON A NEGATIVE RESULT OBTAINED USING LOT NUMBER STA2062002. ON THE (B)(6) AMOXICILLIN 250MG BY 3 WAS ADMINISTERED TO THE PATIENT. THE DOSE ADMINISTERED WAS DEEMED INSUFFICIENT BASED ON WEIGHT OF PATIENT,18 KG. THE PATIENT ARRIVED AT THE EMERGENCY DEPARTMENT WITH CIRCULATORY DEFICIENCY. THE CHILD HAD A BLOTCHY SKIN, WITH DISCOLORATION TIME OF 8 SECONDS. THE PATIENT WAS GIVEN SODIUM CHLORIDE, NACL, AND CRYSTALLOIDS FLUID BY THE INTRAOSTEAL ROUTE. PATIENT DIED AFTER 30 MINUTES OF CARDIO-PULMONARY RESUSCITATION. A RAPID TEST WAS PERFORMED ON FLUID FROM PLEURAL PUNCTURING. THE RESULT OF THE TEST WAS POSITIVE. AUTOPSY TO BE PERFORMED. ALSO, SEVERAL CASES OF SCARLET FEVER WERE REPORTED IN THE SCHOOL IN WHICH THE CHILD ATTENDED. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED. DUE TO INSUFFICIENT INFORMATION PROVIDED UNABLE TO IDENTIFY ANY MISUSE OR DEVIATION AGAINST THE PACKAGE INSERT. NO IMAGES WERE PROVIDED BY THE CUSTOMER FOR REVIEW.
A COMPLAINT WAS RECEIVED BYBIOSYNEX S.A., BASED IN FRANCE, WHO IS A 3RD PARTY MANUFACTURER OF STREP A RAPID TEST STRIP KITS. THE TEST DEVICE CONTAINED IN BIOSYNEX'S KIT IS MANUFACTURED BY ABON BIOPHARM, HANGZHOU, CO., LTD. THIS MDR IS BEING SUBMITTED BY THE DEVICE PRODUCT MANUFACTURER ABON BIOPHARM, HANGZHOU, CO., LTD AS THE DEVICE IN THE TEST KIT IS SAME/SIMILAR TO STREP A PRODUCT CATALOG, IST-501D, THAT IS MARKETED IN THE US. ON THE 23 DECEMBER 2022, BIOSYNEX S.A.3RD PARTY MANUFACTURER, EMAILED TECHNICAL SUPPORT TO REPORT A NOTIFICATION FROM ANSM OF THE DEATH OF A 6 YEAR OLD PATIENT ON (B)(6) 2022 FOLLOWING STREP A MENINGITIS WHERE A NEGATIVE RESULT WAS OBTAINED ON THE (B)(6) 2022 USING STREP A RAPID TEST STRIP, PART NUMBER: IST-501, LOT NUMBER STA2062002. AN ANTIBIOTIC WAS NOT ADMINISTERED TO THE PATIENT ON (B)(6) 2022 BASED ON A NEGATIVE RESULT OBTAINED USING LOT NUMBER STA2062002 . ON THE (B)(6) AMOXICILLIN 250MG BY 3 WAS ADMINISTERED TO THE PATIENT. THE DOSE ADMINISTERED WAS DEEMED INSUFFICIENT BASED ON WEIGHT OF PATIENT,18 KG. THE PATIENT ARRIVED AT THE EMERGENCY DEPARTMENT WITH CIRCULATORY DEFICIENCY. THE CHILD HAD A BLOTCHY SKIN, WITH DISCOLORATION TIME OF 8 SECONDS. THE PATIENT WAS GIVEN SODIUM CHLORIDE, NACL, AND CRYSTALLOIDS FLUID BY THE INTRAOSTEAL ROUTE. PATIENT DIED AFTER 30 MINUTES OF CARDIO-PULMONARY RESUSCITATION. A RAPID TEST WAS PERFORMED ON FLUID FROM PLEURAL PUNCTURING. THE RESULT OF THE TEST WAS POSITIVE. AUTOPSY TO BE PERFORMED. ALSO, SEVERAL CASES OF SCARLET FEVER WERE REPORTED IN THE SCHOOL IN WHICH THE CHILD ATTENDED. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED. DUE TO INSUFFICIENT INFORMATION PROVIDED UNABLE TO IDENTIFY ANY MISUSE OR DEVIATION AGAINST THE PACKAGE INSERT. NO IMAGES WERE PROVIDED BY THE CUSTOMER FOR REVIEW.
A COMPLAINT WAS RECEIVED BY BIOSYNEX S.A., BASED IN FRANCE, WHO IS A 3RD PARTY MANUFACTURER OF STREP A RAPID TEST STRIP KITS. THE TEST DEVICE CONTAINED IN BIOSYNEX'S KIT IS MANUFACTURED BY ABON BIOPHARM, HANGZHOU, CO., LTD. THIS MDR IS BEING SUBMITTED BY THE DEVICE PRODUCT MANUFACTURER ABON BIOPHARM, HANGZHOU, CO., LTD AS THE DEVICE IN THE TEST KIT IS SAME/SIMILAR TO STREP A PRODUCT CATALOG, IST-501D, THAT IS MARKETED IN THE US. ON THE 23 DECEMBER 2022, BIOSYNEX S.A., 3RD PARTY MANUFACTURER, EMAILED TECHNICAL SUPPORT TO REPORT A NOTIFICATION FROM ANSM OF THE DEATH OF A 6 YEAR OLD PATIENT ON (B)(6) 2022 FOLLOWING STREP A MENINGITIS WHERE A NEGATIVE RESULT WAS OBTAINED ON THE (B)(6) 2022 USING STREP A RAPID TEST STRIP, PART NUMBER: IST-501, LOT NUMBER STA2062002. AN ANTIBIOTIC WAS NOT ADMINISTERED TO THE PATIENT ON (B)(6) 2022 BASED ON A NEGATIVE RESULT OBTAINED USING LOT NUMBER STA2062002 . ON THE(B)(6) AMOXICILLIN 250MG BY 3 WAS ADMINISTERED TO THE PATIENT. THE DOSE ADMINISTERED WAS DEEMED INSUFFICIENT BASED ON WEIGHT OF PATIENT,18 KG. THE PATIENT ARRIVED AT THE EMERGENCY DEPARTMENT WITH CIRCULATORY DEFICIENCY. THE CHILD HAD A BLOTCHY SKIN, WITH DISCOLORATION TIME OF 8 SECONDS. THE PATIENT WAS GIVEN SODIUM CHLORIDE, NACL, AND CRYSTALLOIDS FLUID BY THE INTRAOSTEAL ROUTE. PATIENT DIED AFTER 30 MINUTES OF CARDIO-PULMONARY RESUSCITATION. A RAPID TEST WAS PERFORMED ON FLUID FROM PLEURAL PUNCTURING. THE RESULT OF THE TEST WAS POSITIVE. AUTOPSY TO BE PERFORMED. ALSO, SEVERAL CASES OF SCARLET FEVER WERE REPORTED IN THE SCHOOL IN WHICH THE CHILD ATTENDED. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED. DUE TO INSUFFICIENT INFORMATION PROVIDED UNABLE TO IDENTIFY ANY MISUSE OR DEVIATION AGAINST THE PACKAGE INSERT. NO IMAGES WERE PROVIDED BY THE CUSTOMER FOR REVIEW.
A COMPLAINT WAS RECEIVED BY BIOSYNEX S.A., BASED IN FRANCE, WHO IS A 3RD PARTY MANUFACTURER OF STREP A RAPID TEST STRIP KITS. THE TEST DEVICE CONTAINED IN BIOSYNEX'S KIT IS MANUFACTURED BY ABON BIOPHARM, HANGZHOU, CO., LTD. THIS MDR IS BEING SUBMITTED BY THE DEVICE PRODUCT MANUFACTURER ABON BIOPHARM, HANGZHOU, CO., LTD AS THE DEVICE IN THE TEST KIT IS SAME/SIMILAR TO STREP A PRODUCT CATALOG, IST-501D, THAT IS MARKETED IN THE US. ON THE 23 DECEMBER 2022, BIOSYNEX S.A., 3RD PARTY MANUFACTURER, EMAILED TECHNICAL SUPPORT TO REPORT A NOTIFICATION FROM ANSM OF THE DEATH OF A 6 YEAR OLD PATIENT ON (B)(6) 2022 FOLLOWING STREP A MENINGITIS WHERE A NEGATIVE RESULT WAS OBTAINED ON THE (B)(6) 2022 USING STREP A RAPID TEST STRIP, PART NUMBER: IST-501, LOT NUMBER STA2062002. AN ANTIBIOTIC WAS NOT ADMINISTERED TO THE PATIENT ON (B)(6) 2022 BASED ON A NEGATIVE RESULT OBTAINED USING LOT NUMBER STA2062002 . ON THE (B)(6) AMOXICILLIN 250MG BY 3 WAS ADMINISTERED TO THE PATIENT. THE DOSE ADMINISTERED WAS DEEMED INSUFFICIENT BASED ON WEIGHT OF PATIENT,18 KG. THE PATIENT ARRIVED AT THE EMERGENCY DEPARTMENT WITH CIRCULATORY DEFICIENCY. THE CHILD HAD A BLOTCHY SKIN, WITH DISCOLORATION TIME OF 8 SECONDS. THE PATIENT WAS GIVEN SODIUM CHLORIDE, NACL, AND CRYSTALLOIDS FLUID BY THE INTRAOSTEAL ROUTE. PATIENT DIED AFTER 30 MINUTES OF CARDIO-PULMONARY RESUSCITATION. A RAPID TEST WAS PERFORMED ON FLUID FROM PLEURAL PUNCTURING. THE RESULT OF THE TEST WAS POSITIVE. AUTOPSY TO BE PERFORMED. ALSO, SEVERAL CASES OF SCARLET FEVER WERE REPORTED IN THE SCHOOL IN WHICH THE CHILD ATTENDED. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED. DUE TO INSUFFICIENT INFORMATION PROVIDED UNABLE TO IDENTIFY ANY MISUSE OR DEVIATION AGAINST THE PACKAGE INSERT. NO IMAGES WERE PROVIDED BY THE CUSTOMER FOR REVIEW.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 128927 | BIOSYNEX STREPTATEST | STEP A RAPID TEST STRIP | GTY | ABON BIOPHARM (HANGZHOU) CO., LTD. | IST-501 | STA2062002 | |
| 1859285 | BIOSYNEX STREPTATEST | STEP A RAPID TEST STRIP | GTY | ABON BIOPHARM (HANGZHOU) CO., LTD. | IST-501 | STA2062002 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 6 YR | Female | Death | AMOXICILLIN |