MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2011-09-13 for CLINICAL CHEMISTRY ALKALINE PHOSPHATASE REAGENT 07D55-31 manufactured by Abbott Manufacturing Inc.
[2383531]
The customer observed high absorbance values for calibration of the clinical chemistry alkaline phosphatase assay since the first use of reagent lot 08145un11 on (b)(6) 2011. The customer stated quality controls were unaffected and no calibration failures or patient exceptions were observed. The customer did observe block spots inside the alkaline phosphatase reagent cartridges and performed microscopy. The customer determined the reagent's dark color was the result of fungal elements present in the reagent and requested replacement reagents. There was no impact to patient management.
Patient Sequence No: 1, Text Type: D, B5
[9392049]
No consequences or impact to patient. 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 | 1628664-2011-00611 |
| MDR Report Key | 2246990 |
| Report Source | 01 |
| Date Received | 2011-09-13 |
| Date of Report | 2011-08-16 |
| Date of Event | 2011-08-13 |
| Date Mfgr Received | 2011-08-16 |
| Device Manufacturer Date | 2011-03-24 |
| Date Added to Maude | 2011-10-21 |
| 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 | 2011-09-13 |
| Catalog Number | 07D55-31 |
| Lot Number | 08145UN11 |
| Device Expiration Date | 2012-02-15 |
| 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 | 2011-09-13 |