MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2011-09-16 for CLINICAL CHEMISTRY ALKALINE PHOSPHATASE REAGENT 07D55-31 manufactured by Abbott Manufacturing Inc.
[20911983]
The customer observed mold in the r2 reagent of clinical chemistry alkaline phosphatase reagent lot 62474un10. The customer was sent a replacement lot of reagent. There was no impact to patient management.
Patient Sequence No: 1, Text Type: D, B5
[21222325]
(b)(4). The cause of the clinical chemistry alkaline phosphatase reagents failed to calibrate/generate results was due to visible particulate or visible mold in the reagent cartridges. Abbott issued a product recall letter to all customers to inform them to discontinue use and to discard/destroy any suspect cartridges and order replacement reagents.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1628664-2011-00615 |
| MDR Report Key | 2250927 |
| Report Source | 01 |
| Date Received | 2011-09-16 |
| Date of Report | 2011-08-30 |
| Date of Event | 2011-08-30 |
| Date Mfgr Received | 2011-08-30 |
| Device Manufacturer Date | 2010-12-03 |
| Date Added to Maude | 2012-05-10 |
| 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 MANUFACTURING INC |
| Manufacturer Street | 1921 HURD DRIVE |
| Manufacturer City | IRVING TX 75038 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 75038 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 1628664-8/29/11-001-R |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLINICAL CHEMISTRY ALKALINE PHOSPHATASE REAGENT |
| Product Code | CJE |
| Date Received | 2011-09-16 |
| Catalog Number | 07D55-31 |
| Lot Number | 62474UN10 |
| Device Expiration Date | 2011-11-19 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT MANUFACTURING INC |
| Manufacturer Address | 1921 HURD DRIVE IRVING TX 75038 US 75038 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-09-16 |