ALINITY I STAT CK-MB REAGENT KIT
Received Jun 5, 2023 · Event occurred May 18, 2023
Report 3008344661-2023-00099 · MDR key 17058229
Device
Generic name
Fluorometric Method, Cpk Or Isoenzymes
Manufacturer
Abbott Ireland Diagnostics DivisionCatalog number
04V38-20
Lot number
40028FN00
Product problems
- High Test Results
- High Test Results
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I STAT CK-MB RESULTS FOR A 91-YEAR-OLD FEMALE PATIENT. THE PATIENT¿S PREVIOUS RESULT WAS 4.0 NG/ML (B)(6) 2023 6:56 SID (B)(6)= 79.40 NG/ML. (B)(6) 2023 7:52 SID (B)(6) = 20.88 NG/ML. (B)(6) 2023 8:10 SID (B)(6)= 21.63 NG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Additional Manufacturer Narrative
AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. COMPLETED INFORMATION FOR SECTION A1 PATIENT IDENTIFICATION: (B)(6). COMPLETED INFORMATION FOR SECTION E1 PHONE NUMBER : (B)(6). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 04V38-20 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 4V38-21 / 31. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.
Additional Manufacturer Narrative
THE COMPLAINT INVESTIGATION FOR FALSELY ELEVATED ALINITY I STAT CK-MB RESULTS INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, DEVICE HISTORY RECORD REVIEW, AND IN-HOUSE TESTING. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY ANY TRENDS FOR THE COMPLAINT ISSUE. DEVICE HISTORY RECORD REVIEW ON LOT 40028FN00 DID NOT SHOW ANY POTENTIAL NON-CONFORMANCES, DEVIATIONS, OR NON-CONFORMANCES ASSOCIATED WITH THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE. IN-HOUSE ACCURACY TESTING WAS COMPLETED USING AN IN-HOUSE RETAINED KIT OF LOT 40028FN00. ALL SPECIFICATIONS WERE MET INDICATING THAT THE LOT IS PERFORMING ACCEPTABLY. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I STAT CK-MB ASSAY FOR LOT NUMBER 40028FN00 WAS IDENTIFIED. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.
Description of Event or Problem
THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I STAT CK-MB RESULTS FOR A 91-YEAR-OLD FEMALE PATIENT. THE PATIENT¿S PREVIOUS RESULT WAS 4.0 NG/ML (B)(6) 2023 6:56 SID (B)(6) = 79.40 NG/ML. (B)(6) 2023 7:52 SID (B)(6) = 20.88 NG/ML. (B)(6) 2023 8:10 SID (B)(6) = 21.63 NG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.