KIT, TRIAGE, CARDIAC TNI / CKMB
Received Jan 19, 2016 · Event occurred May 28, 2015
Report 2027969-2016-00032 · MDR key 5377612
Device
Generic name
Cardiac Marker Test
Manufacturer
Alere San Diego, Inc.Model number
97022HSLot number
W59490RB
Product problems
- False Negative Result
- Incorrect, Inadequate or Imprecise Result or Readings
- False Negative Result
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
DEVICE PRODUCT CODE (CONTINUED): DDR, JHX AND MMI. INVESTIGATION/CONCLUSION: IT IS INDICATED THAT THE PRODUCT IS NOT RETURNING FOR EVALUATION. SINCE THE PRODUCT ASSOCIATED WITH THE COMPLAINT WAS NOT RETURNED, A REVIEW OF IN-HOUSE TESTING HISTORY FOR THE LOT WAS PERFORMED AND THE RESULTS WERE WITHIN FINAL RELEASE SPECIFICATIONS. THE PRODUCT PERFORMED AS EXPECTED AND NO PRODUCT DEFICIENCIES WERE OBSERVED. THE MANUFACTURING RECORDS FOR THE LOT WERE REVIEWED AND THE LOT MET RELEASE SPECIFICATIONS. THE CUSTOMER DID NOT RETURN A SAMPLE; THEREFORE SAMPLE SPECIFIC INTERFERENCE IS UNABLE TO BE RULED OUT AS A POTENTIAL CAUSE FOR DISCREPANT RESULTS. THE ROOT CAUSE FOR THE ALLEGED DISCREPANT LOW TROPONIN COMPLAINT COULD NOT BE DETERMINED. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY AND NO CORRECTIVE ACTION IS REQUIRED.
Description of Event or Problem
THE CUSTOMER ALLEGED A VARIANCE BETWEEN THE TRIAGE TROPONIN (TNI) RESULT IN COMPARISON TO THE BECKMAN DXI 800 LABORATORY ANALYZER. RESULTS ARE AS FOLLOWS: DATE: (B)(6) 2015, TRIAGE TNI: <0.05, LABORATORY TNI: 0.18. THE TRIAGE TNI WAS WITHIN THE CUSTOMERS ASSIGNED "NORMAL" RESULT RANGE AND THE LABORATORY TNI WAS IN AN "INDETERMINATE" RESULT RANGE. THERE WERE NO REPORTED ADVERSE EVENTS RELATED TO THE TRIAGE RESULT AND NO PATIENT SPECIFIC INFORMATION PROVIDED.