MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2012-04-02 for ARCHITECT STAT CK-MB 02K42-20 manufactured by Abbott Laboratories.
[2597696]
The customer stated that several patient samples generated discrepant results for the architect ck-mb assay. The results were discrepant on the architect verses two other (non-abbott) methods (vidas and advia). Data from (b)(4) patients was provided, (b)(4) of which generated clinically discrepant results between the architect and the other two methods. The cut-off point the customer is using for the architect is 6. 6 ng/ml, for vidas 5. 1 and for advia is 5. 0 ng/ml. One patient sample generated a positive result of 10. 5 ng/ml on the architect compared to a negative result on advia. Suspect results were not reported out and no impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
[9708658]
(b)(4). Product evaluation is in process and the results will be submitted in a follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[9816976]
Product evaluation was conducted to investigate this issue. Customer complaints received to-date were reviewed to determine if others have experienced the issue encountered at this facility. The review did not identify an increase in complaint activity for lot 44152un10. Testing using reagent lot 44152un10 was performed in order to determine if the assay could accurately read varying concentrations of ck-mb. One architect instrument was calibrated and controls were run to validate the run. Six replicates of two panels with known concentrations of ck-mb were tested and the results were evaluated against their specifications. The concentrations for each of the panels were within specification, which indicated that the assay is capable of accurately reading varying concentrations of ck-mb. Based on this investigation, it was determined that the architect stat ck-mb assay is performing acceptably. No deficiency was identified related to the alleged malfunction reported by the customer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-2012-00107 |
| MDR Report Key | 2513035 |
| Report Source | 01 |
| Date Received | 2012-04-02 |
| Date of Report | 2012-03-09 |
| Date of Event | 2012-02-28 |
| Date Mfgr Received | 2012-04-13 |
| Date Added to Maude | 2012-09-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | NOEMI ROMERO-KONDOS, RN BSN |
| Manufacturer Street | 100 ABBOTT PARK ROAD DEPT. 09B9, LCCP1-3 |
| Manufacturer City | ABBOTT PARK IL 600643537 |
| Manufacturer Country | US |
| Manufacturer Postal | 600643537 |
| Manufacturer Phone | 847937-512 |
| Manufacturer G1 | ABBOTT LABORATORIES |
| Manufacturer Street | 100 ABBOTT PARK ROAD |
| Manufacturer City | ABBOTT PARK IL 60064350 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60064 3500 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARCHITECT STAT CK-MB |
| Product Code | JLB |
| Date Received | 2012-04-02 |
| Catalog Number | 02K42-20 |
| Lot Number | 44152UN10 |
| Device Expiration Date | 2012-03-31 |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 100 ABBOTT PARK ROAD ABBOTT PARK IL 60064350 US 60064 3500 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-04-02 |