MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-08-30 for CLINICAL CHEMISTRY ALKALINE PHOSPHATASE REAGENT 7D55-31 manufactured by Abbott Manufacturing Inc.
[2328404]
Abbott received multiple complaints for clinical chemistry alkaline phosphatase reagent lots 62474un10, 71628un10 and 08145un11, where reagent cartridges have been reported to contain visible mold/particulate matter inside the r2 cartridges. In house testing was performed on the reagents lots which generated either acceptable results or failure to calibrate/generate results with an active calibration. The reagents were sent to the armstrong forensic laboratory for fungal/bacterial culturing with identification and the lab confirmed the presence of cladosporium species of mold. A product recall has been issued and reported under 21cfr806 for the clinical chemistry alkaline phosphatase reagent to the fda (b)(4) district on august 29, 2011. Abbott has not received any reports of adverse events related to this issue.
Patient Sequence No: 1, Text Type: D, B5
[9258616]
Suspect medical device, additional lots: lot 71628un10, date of manufacturing: 12/29/10, expiration date: 11/19/11, lot 08145un10, date of manufacturing: 3/24/11, expiration date: 2/15/12. No consequences or impact to patient. (b)(4): contamination during use; 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 | 1628664-2011-00572 |
| MDR Report Key | 2226683 |
| Report Source | 07 |
| Date Received | 2011-08-30 |
| Date of Report | 2011-08-16 |
| Date of Event | 2011-08-16 |
| Date Mfgr Received | 2011-08-16 |
| Device Manufacturer Date | 2011-01-04 |
| 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 LABORATORIES |
| Manufacturer Street | 100 ABBOTT PARK ROAD |
| Manufacturer City | ABBOTT PARK IL 60064350 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60064 3500 |
| 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 | 2011-08-30 |
| Catalog Number | 7D55-31 |
| Lot Number | 62474UN10 |
| Device Expiration Date | 2011-11-19 |
| Operator | OTHER |
| 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 | 2011-08-30 |