MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2010-02-24 for AXSYM CK-MB 7A57-20 manufactured by Abbott Laboratories.
[1319941]
The customer states that a sample from one patient processed using the axsym ck mb assay generated a falsely decreased result. No adverse impact to patient management was reported related to this issue.
Patient Sequence No: 1, Text Type: D, B5
[8515082]
(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 | 1628664-2010-00095 |
| MDR Report Key | 1613620 |
| Report Source | 01 |
| Date Received | 2010-02-24 |
| Date of Report | 2010-02-11 |
| Date of Event | 2010-02-11 |
| Date Mfgr Received | 2010-03-29 |
| Device Manufacturer Date | 2009-12-23 |
| Date Added to Maude | 2010-11-18 |
| 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 KONDOS RN, BSN |
| Manufacturer Street | 200 ABBOTT PARK ROAD DEPT. 09B9, AP50 |
| Manufacturer City | ABBOTT PARK IL 600643537 |
| Manufacturer Country | US |
| Manufacturer Postal | 600643537 |
| Manufacturer Phone | 8479375120 |
| 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 | AXSYM CK-MB |
| Generic Name | FOR THE QUANTITATIVE DETERMINATION OF THE MB ISOENZYME OF CREATINE KINASE |
| Product Code | JHW |
| Date Received | 2010-02-24 |
| Catalog Number | 7A57-20 |
| Lot Number | 83465Q100 |
| Device Expiration Date | 2010-12-21 |
| Operator | OTHER |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2010-02-24 |