8031673-2017-00040
Report
- Report Number
- 8031673-2017-00040
- Event Type
- Malfunction
- Date Received
- September 30, 2017
- Date of Event
- August 30, 2017
- Report Date
- April 5, 2018
- PMA / PMN Number
- K971103
- Removal / Correction Number
- 3005529799-2/21/18-004-R
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
H.10. ADDITIONAL MANUFACTURER NARRATIVE: TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE IMPORTER OR MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT. H.3. DEVICE EVALUATION BY MANUFACTURER: DEVICE EVALUAITON IN-PROGRESS. NO CONCLUSION CAN BE DRAWN AT THIS TIME.
TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. DEVICE EVALUATION BY MANUFACTURER: DEVICE EVALUATION IN-PROGRESS. NO CONCLUSION CAN BE DRAWN AT THIS TIME. CORRECTED DATA: REPORT SOURCE: UNDER THE ABOVE SECTION "USER FACILITY" WAS INCORRECTLY SELECTED. THE ONLY REPORT SOURCE IS "HEALTH PROFESSIONAL".
ADDITIONAL MANUFACTURER NARRATIVE: TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE IMPORTER OR MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT. DEVICE EVALUATION BY MANUFACTURER: INVESTIGATION INTO THIS ISSUE BY TOSOH HAS DETERMINED THAT THE ST AIA-PACK HBA1C ASSAY CAN POTENTIALLY GENERATE ERRONEOUSLY ELEVATED OR ERRONEOUSLY DECREASED HBA1C PATIENT RESULTS ON THE AIA SYSTEMS. THE INVESTIGATION CONFIRMED INCONSISTENT OR UNEXPECTED VARIABILITY OF HBA1C RESULTS WHEN COMPARING TOSOH'S ST AIA-PACK HBA1C TO ALTERNATIVE HBA1C TESTING. RISK TO HEALTH: A FALSELY ELEVATED OR FALSELY LOW HBA1C RESULT MAY NOT BE EASILY RECOGNIZED WHEN THERE IS NO PATIENT HISTORY OR CLINICAL PICTURE, WHICH WOULD INDICATE THAT AN INCORRECT TEST RESULT WAS OBTAINED. IN CURRENT MEDICAL PRACTICE, SINGLE HBA1C BLOOD MEASUREMENTS ARE THE PRIMARY INDICATOR OF THE DEGREE OF SUSTAINED GLYCEMIC CONTROL AND IT IS NOT CURRENT PRACTICE TO CORROBORATE A BLOOD HBA1C RESULT ON AN ALTERNATIVE SYSTEM. DEVICE FAILURE MAY BE EASILY RECOGNIZED GIVEN A PATIENT HISTORY OR CLINICAL PICTURE, WHICH IS NOT CONSISTENT WITH THE REPORTED RESULT, WHICH IS MOST LIKELY TO OCCUR UNDER A RIGOROUS AND ROUTINE MEDICAL CARE OR IN A HOSPITAL SETTING, SUCH AS AN INTENSIVE CARE UNIT, WHERE INTENSE CLINICAL OBSERVATION OCCURS. HOWEVER, BECAUSE HBA1C LEVELS ARE EXTENSIVELY USED IN THE OUTPATIENT SETTING AT WIDE TIME INTERVALS AS THE SINGLE RELIABLE TEST TO MONITOR GLYCEMIC CONTROL, DEVICE FAILURE IS NOT EASILY RECOGNIZED BY THE USER IN THIS SETTING. THE AMERICAN DIABETES ASSOCIATION (ADA) RECOMMENDS MEASUREMENT OF HBA1C (TYPICALLY 3-4 TIMES PER YEAR FOR TYPE 1 AND POORLY CONTROLLED TYPE 2 DIABETIC PATIENTS, AND 2 TIMES PER YEAR FOR WELL-CONTROLLED TYPE 2 DIABETIC PATIENTS) TO DETERMINE WHETHER A PATIENT'S GLYCEMIC METABOLIC CONTROL HAS REMAINED CONTINUOUSLY WITHIN THE TARGET RANGE. IMMEDIATE HEALTH CONSEQUENCES OF A FALSELY LOW OR FALSELY NORMAL HBA1C RESULT INCLUDE THE FAILURE OF THE HEALTHCARE PRACTITIONER TO RECOGNIZE VERY POOR AND DETERIORATING GLYCEMIC CONTROL IN KNOWN DIABETICS WHO ARE NOT YET IN A STATE OF KETOACIDOSIS, WITH THE RESULTING CONSEQUENCE OF THE SUBSEQUENT DEVELOPMENT OF LIFE-THREATENING DIABETIC KETOACIDOSIS. LONG-RANGE HEALTH CONSEQUENCES OF FALSELY LOW OR FALSELY NORMAL HBA1C LEVELS INCLUDE THE FAILURE TO RECOGNIZE AND MANAGE INADEQUATE GLYCEMIC CONTROL WITH THE CONSEQUENCES OF LONG-RANGE RISKS FOR BOTH THE INDIVIDUAL PATIENT AND THE PUBLIC HEALTH. THESE RISKS OF SUSTAINED POOR GLYCEMIC CONTROL FOR THE INDIVIDUAL DIABETIC AND THE PUBLIC HEALTH INCLUDE THE DEVELOPMENT OF DIABETIC NEUROPATHY (INCLUDING AMPUTATION); RETINOPATHY (INCLUDING BLINDNESS); DIABETIC RENAL DISEASE (INCLUDING END STAGE RENAL FAILURE AND NEED FOR DIALYSIS), AND MACRO-VASCULAR DISEASE (INCLUDING CARDIOVASCULAR EVENTS). IMMEDIATE AND LONG-TERM HEALTH CONSEQUENCES OF FALSELY ELEVATED HBA1C LEVELS INCLUDE THE UNNECESSARY ADDITION OF POTENT GLUCOSE-LOWERING DRUGS OR THE UNNECESSARY INCREASE IN DRUG DOSAGE IN KNOWN DIABETICS, WITH THE RISK OF HYPOGLYCEMIA, INCLUDING THE LIFE-THREATENING RISK OF COMA AND LOSS OF CONSCIOUSNESS AS WELL AS OTHER DISABLING SYMPTOMS OF HYPOGLYCEMIA. HEALTH RISKS OF FALSELY LOW LEVELS ALSO INCLUDE THE RISK OF FAILURE TO DIAGNOSE DIABETES, AS WELL AS THE RISK OF FAILURE TO DIAGNOSE PATIENTS AT INCREASED RISK FOR DIABETES (PREDIABETES). IN ORDER TO PREVENT ANY RISK TO HEALTH, TOSOH HAS TAKEN THE FOLLOWING ACTIONS: IMMEDIATE ACTIONS TO BE TAKEN BY THE CUSTOMER IMMEDIATELY DISCONTINUE USE OF ALL LOT NUMBERS OF THE ST AIA-PACK HBA1C TEST AND COMPONENTS. IMMEDIATELY REMOVE ALL ST AIA-PACK HBA1C TEST AND COMPONENTS MATERIALS/KITS FROM THEIR INVENTORY. REVIEW THE INFORMATION PROVIDE BY TOSOH WITH THE MEDICAL DIRECTOR AND/OR LAB DIRECTOR. IMMEDIATELY NOTIFY AND FORWARD THIS INFORMATION TO PHYSICIANS WHO HAVE RECEIVED TEST RESULTS THAT HAD BEEN PROVIDED BY THE RECALLED PRODUCTS OVER THE PAST 6 MONTHS SO THAT THEY MAY DETERMINE IF FOLLOW-UP TESTING IS REQUIRED (E.G. IF THE HBA1C RESULTS THEY RECEIVED DID NOT MATCH OTHER PATIENT DATA SUCH AS SYMPTOMS, RESULTS OF OTHER TESTS (TYPICALLY BLOOD GLUCOSE LEVELS), OR CLINICAL IMPRESSIONS, OR RESULTS WHICH SHOWED INCONSISTENT TEST VALUES) IMMEDIATELY IDENTIFY AN ALTERNATIVE TEST OPTION FOR YOUR HBA1C TESTING NEEDS. TOSOH IS PERMANENTLY REMOVING THE ST AIA-PACK HBA1C TEST AND COMPONENTS FROM THE MARKET.
ON (B)(6) 2017 A CUSTOMER REPORTED HBA1C PATIENT RESULT OF 6.4% (ASSAY RANGE 3.0 - 14.0%) ON THE AIA-900 SYSTEM, WHICH DID NOT CORRELATE WITH THE PATIENT CLINICAL HISTORY AND WAS QUESTIONED BY THE PHYSICIAN. THE PATIENT WAS NOT PRE-DIABETIC. THE PATIENT SAMPLE WAS SENT OUT TO (B)(6) (METHODOLOGY NOT KNOWN) FOR CONFIRMATION AND THE HBA1C RESULT OBTAINED WAS 5.2%. THE PATIENT SAMPLE WAS COLLECTED AND RAN ON (B)(6) 2017 IN AN EDTA TUBE. BASED ON THIS RESULT, THE PHYSICIAN SUSPENDED ANY FURTHER HBA1C TESTING ON THE AIA-900 UNTIL THE ISSUE IS RESOLVED. THE CUSTOMER IS SENDING OUT THE HBA1C FOR TESTING. THERE IS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.
N/A.
N/A.
(B)(4), PER EXEMPTION NUMBER E2017013. DEVICE EVALUATION BY MANUFACTURER: TOSOH ROOT CAUSE INVESTIGATION DETERMINED THAT INDUSTRY STANDARDS AND EXPECTATIONS OF PERFORMANCE HAVE CHANGED SINCE THE INTRODUCTION OF THE ST AIA-PACK HBA1C ASSAY. IN ORDER FOR THE ASSAY TO BE USEFUL, IT WOULD BE NECESSARY TO REDUCE LOT TO LOT VARIABILITY OF REAGENT TO WELL BELOW 6% TO ALLOW FOR HUMAN FACTORS; TOSOH'S RELEASE SPECIFICATION IS +/- 10%. THE ROOT CAUSE INVESTIGATION CONFIRMED THAT THE ST AIA-PACK HBA1C EXHIBITS LOT TO LOT VARIABILITY WITHIN THE +/- 10%. THE ST AIA-PACK HBA1C RESULTS ARE INFLUENCED BY A NUMBER OF FACTORS, INCLUDING OPERATOR SKILLS AND SPECIMEN QUALITY, WHICH MAY INCREASE VARIABILITY. TOSOH ST AIA-PACK HBA1C CANNOT MEET CURRENT REQUIREMENTS.
N/A.
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |