ERYTYPE S ABD+REV A1,B
Report
- Report Number
- 9610824-2021-00039
- Event Type
- Malfunction
- Date Received
- June 2, 2021
- Date of Event
- April 30, 2021
- Report Date
- July 12, 2021
- Manufacturer
- BIO-RAD MEDICAL DIAGNOSTICS GMBH
- Product Code
- QHR
- UDI-DI
- 07611969951147
- PMA / PMN Number
- 125094
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
THIS IS OUR FINAL REPORT ON THIS INCIDENT.
THIS IS OUR INITIAL REPORT ON THIS INCIDENT.
THE CUSTOMER REPORTED THAT A DONOR SAMPLE SHOWED A FALSE NEGATIVE RESULT WITH ANTI-D OF ERYTYPE S ABD+REV.A1, B ON TANGO INFINITY. THE CUSTOMER STATED THAT THE DONOR SAMPLE SHOULD BE USED AS A O RHD NEGATIVE CONTROL BUT IT SHOWED A WEAK POSITIVE REACTION WITH THE ANTI-D OF ERYTYPE RH CONFIRM ON TANGO INFINITY. BASED ON THIS RESULT THE CUSTOMER TESTED THE DONOR SAMPLE WITH SERACLONE ANTI-D BLEND IN THE TUBE TECHNIQUE. THE SAMPLE SHOWED A NEGATIVE "RESULT" IN THE IMMEDIATE SPIN TEST, BUT A POSITIVE RESULT IN THE INDIRECT ANTIGLOBULIN TEST (IAT). THE CUSTOMER DID NOT RETURN THE COMPLAINT SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT ERYTYPE S ABD+REV.A1, B, BUT THE DONOR SAMPLE (#(B)(6)) THAT HAD CAUSED A FALSE NEGATIVE TEST RESULT. THE DONOR SAMPLE WAS SEPARATED IN PLASMA AND RED BLOOD CELLS. ADDITIONALLY, THE CUSTOMER RETURNED SERACLONE ANTI- D BLEND. OUR QUALITY CONTROL LABORATORY TESTED THE DONOR SAMPLE WITH THEIR RETENTION SAMPLE OF ERYTYPE S ABD+REV.A1, B AND COULD CONFIRM THE CUSTOMER´S FINDING. ADDITIONALLY, THE DONOR SAMPLE WAS TESTED WITH SERACLONE ANTI-D BLEND IN THE TUBE TECHNIQUE. AGAIN, THE CUSTOMER´S FINDING COULD BE CONFIRMED: A NEGATIVE RESULT IN THE IMMEDIATE SPIN TEST, BUT A POSITIVE RESULT IN THE IAT. DUE TO THE SEROLOGICAL TEST RESULTS A WEAK D RESPECTIVELY A D VARIANT WAS SUSPECTED. THEREFORE, THE DONOR SAMPLE WAS SENT FOR MOLECULAR TYPING TO AN EXTERNAL LABORATORY. THE RESULT OF THE EXTERNAL EXAMINATION WAS CCD.EE WEAK D TYPE 1 (ISBT: RHD*01W.1). FURTHERMORE, THE RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT ERYTYPE S ABD+REV. A1, B WAS TESTED WITH DIFFERENT DONOR SAMPLES ON TANGO INFINITY. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. BASED ON THE INVESTIGATION THE COMPLAINT WAS CLASSIFIED AS CONFIRMED - EPP (EXPECTED PRODUCT PERFORMANCE). THE PATIENT SAMPLE WAS TYPED AS CCD.EE WEAK D TYPE 1 (ISBT: RHD*01W.1). THIS RESULT MATCHED THE SEROLOGICAL RESULTS, BOTH AT THE CUSTOMER'S SITE AND IN OUR QUALITY CONTROL LABORATORY. THE INSTRUCTIONS FOR USE BLOOD GROUPING REAGENT ERYTYPE® S ABD+REV. A1,B CONTAINED A CORRESPONDING NOTE IN THE SECTION IMITATIONS: "CATEGORY VII AND VERY WEAK EXPRESSIONS OF THE D ANTIGEN (D WEAK WITH VERY FEW RECEPTORS) WILL GIVE WEAKENED OR NEGATIVE REACTIONS WITH THE ANTI-D REAGENTS ON THIS STRIP." A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. REGARDING THE AFFECTED TANGO INFINITY, THE RECEIVED DATABASES AND LOG FILES WERE ANALYZED FOR ANY ISSUE RELEVANT ANOMALIES. A FIELD SERVICE ENGINEER CHECKED THE INSTRUMENT AND FOUND THE INSTRUMENT TO BE OPERATING PER SPECIFICATIONS AND REMAINING IN OPERATION. BASED ON CURRENT INFORMATION AND DATA THERE IS NO INDICATION FOR AN INSTRUMENT MALFUNCTION. THE QC PASSED AT THE DAYS OF ISSUE. THE RESULT WAS NEGATIVE FOR RH(D) IN BOTH WELLS AND ON BOTH DAYS OF TESTING. AS THE ABOVE LIMITATION DESCRIBES, WEAK D TYPE 1 MAY SHOW WEAK TO NEGATIVE REACTIONS ON THE USED ERYTYPE S CONFIGURATION. THE REPORTED PROBLEM IS RELATED TO SAMPLE SPECIFICITIES.
THE CUSTOMER REPORTED THAT A DONOR SAMPLE SHOWED A FALSE NEGATIVE RESULT WITH ANTI-D OF ERYTYPE S ABD+REV.A1, B ON TANGO INFINITY. THE CUSTOMER STATED THAT THE DONOR SAMPLE SHOULD BE USED AS A O RHD NEGATIVE CONTROL. BUT THEN THE DONOR SAMPLE SHOWED A WEAK POSITIVE REACTION WITH THE ANTI-D OF ERYTYPE RH CONFIRM ON TANGO INFINITY. BASED ON THIS RESULT THE CUSTOMER TESTED THE DONOR SAMPLE WITH SERACLONE ANTI-D BLEND IN THE TUBE TECHNIQUE. THE SAMPLE SHOWED A NEGATIVE RESULT IN THE IMMEDIATE SPIN TEST, BUT A POSITIVE RESULT IN THE INDIRECT ANTIGLOBULIN TEST (IAT). THE CUSTOMER DID NOT RETURN THE COMPLAINT SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT ERYTYPE S ABD+REV.A1, B, BUT THE DONOR SAMPLE ((B)(6)) THAT HAD CAUSED A FALSE NEGATIVE TEST RESULT. THE DONOR SAMPLE WAS SEPARATED IN PLASMA AND RED BLOOD CELLS. ADDITIONALLY, THE CUSTOMER RETURNED SERACLONE ANTI- D BLEND. OUR QUALITY CONTROL LABORATORY TESTED THE DONOR SAMPLE WITH THEIR RETENTION SAMPLE OF ERYTYPE S ABD+REV.A1, B AND COULD CONFIRM CUSTOMER´S FINDING. ADDITIONALLY, THE DONOR SAMPLE WAS TESTED WITH SERACLONE ANTI-D BLEND IN THE TUBE TECHNIQUE. AGAIN, THE CUSTOMER´S FINDING COULD BE CONFIRMED: A NEGATIVE RESULT IN THE IMMEDIATE SPIN TEST, BUT A POSITIVE RESULT IN THE IAT. DUE TO THE SEROLOGICAL TEST RESULTS A WEAK D RESPECTIVELY A D VARIANT WAS SUSPECTED. THEREFORE, THE DONOR SAMPLE WAS SENT FOR MOLECULAR TYPING TO AN EXTERNAL LABORATORY. WE ARE STILL WAITING FOR THE RESULT. THE CUSTOMER PROVIDED RESULT IMAGES THAT CONFIRM THE NEGATIVE RESULTS USING ABD+REV. A1,B PLATE AND POSITIVE TO INTERMEDIATE RESULTS USING ERYTYPE S RHD CONFIRM PLATE. A FIELD SERVICE ENGINEER COLLECTED THE REQUESTED FILES AND VIEWED THE INSTRUMENT LOG. THE INSTRUMENT IS OPERATING PER SPECIFICATIONS AND REMAINS IN OPERATION. THE LOG FILES CONFIRM THE DISCREPANT RESULTS BETWEEN BOTH ASSAYS (PLATE TYPES). WE ARE STILL WAITING FOR THE OUTCOME OF THE MOLECULAR TYPING. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 818137 | ERYTYPE S ABD+REV A1,B | ERYTYPE S ABD+REV A1,B | QHR | BIO-RAD MEDICAL DIAGNOSTICS GMBH | 8012230 | 07611969951147 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | ERYTYPE RH CONFIRM, LOT 8006150.| ERYTYPE RH CONFIRM, LOT 8006150.| TANGO INFINITY, SN (B)(6).| TANGO INFINITY, SN (B)(6). |