MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-11-09 for ARCHITECT STAT MYOGLOBIN REAGENT 02K43-25 manufactured by Abbott Laboratories.
[3030398]
The customer observed falsely decreased architect myoglobin results. The (b)(6) male patient presented with chest pain and shortness of breath. The customer provided the following results, unit of measures not provided: initial result using serum (architect myoglobin) 39. 1 (normal is <140). The patient was retested with wholeblood using a different method (triage) and generated a result of 162 (normal range provided 0. 0-107). The patient sample was re-run using the architect myoglobin assay generating a result of 42. 2. The patient sample was sent to another lab and tested by another method (lab corp myoglobin) generating a result of 40. There has been no impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5
[10310643]
(b)(4). An evaluation is in process. A follow-up report will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
[10606603]
Further investigation of the customer issue included a review of the complaint text, in-house testing, a search for similar complaints, and a review of labeling. An accuracy testing protocol was executed using lot 32624un12; testing met the acceptance criteria and determined the reagent is performing acceptably. Tracking and trending did not identify an adverse trend. Labeling was reviewed and found to be adequate. Labeling also does not support the comparison of the architect stat myoglobin assay to other methods. Based on the available information no product deficiency and no malfunction of the architect stat myoglobin reagent list number 02k43, lot number 32624un12, was identified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-2012-02072 |
| MDR Report Key | 2827054 |
| Report Source | 05 |
| Date Received | 2012-11-09 |
| Date of Report | 2012-10-23 |
| Date of Event | 2012-10-23 |
| Date Mfgr Received | 2013-03-22 |
| Device Manufacturer Date | 2013-07-31 |
| Date Added to Maude | 2012-11-16 |
| 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 MYOGLOBIN REAGENT |
| Product Code | DDR |
| Date Received | 2012-11-09 |
| Catalog Number | 02K43-25 |
| Lot Number | 32624UN12 |
| Device Expiration Date | 2012-03-01 |
| 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 | 2012-11-09 |