MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2011-11-17 for ARCHITECT STAT MYOGLOBIN 02K43-25 manufactured by Abbott Laboratories.
[18743380]
Precision testing was performed using an in-house file kit of architect stat myoglobin (b)(4) reagent lot 22396un11. Precision testing results met the acceptance criteria. Customer complaint data was reviewed and no adverse trends were identified. The architect stat myoglobin reagent package insert was reviewed and was found to adequately address the issue. The investigation did not identify a product deficiency.
Patient Sequence No: 1, Text Type: N, H10
[21294743]
The account stated that a low architect myoglobin result of 8. 3 ng/ml was generated. The sample was repeated after 2 hours and a result of 119. 8 ng/ml was generated. A second sample was obtained 2 hours later and a result of 112 ng/ml was generated. There was no report of impact to patient management.
Patient Sequence No: 1, Text Type: D, B5
[21517876]
(b)(4). An investigation is in process. A follow-up report will be submitted when the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-2011-00687 |
| MDR Report Key | 2341225 |
| Report Source | 01,05 |
| Date Received | 2011-11-17 |
| Date of Report | 2011-11-02 |
| Date of Event | 2011-10-28 |
| Date Mfgr Received | 2012-01-11 |
| Device Manufacturer Date | 2011-04-01 |
| Date Added to Maude | 2011-12-14 |
| 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 |
| Product Code | DDR |
| Date Received | 2011-11-17 |
| Catalog Number | 02K43-25 |
| Lot Number | 22396UN11 |
| Device Expiration Date | 2012-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2011-11-17 |