MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-04-17 for CREATININE 03L81-22 manufactured by Abbott Manufacturing Inc.
[142346956]
The information provided and troubleshooting performed by the customer was reviewed. The customer repeated the sample on the same and alternate architect analyzer and obtained 0. 8 mg/dl. In addition, the customer did precision studies using quality control material that met the package insert precision claim. The customer also performed 6052 wash cuvette maintenance, qc was within range and the assay is performing within assay insert claims. Ticket searches for lot 55733un18 did not identify any other complaints. Tracking and trending report review for the architect creatinine assay did not identify any trends associated with the complaint issue. Manufacturing documentation for the likely cause lot was reviewed and did not identify any issues. Labeling was reviewed and sufficiently addresses the customer's issue. No systemic issue or deficiency of the architect creatinine assay was identified.
Patient Sequence No: 1, Text Type: N, H10
[142346957]
The customer reported a falsely elevated architect creatinine result. The sample generated an initial result of 14. 6 mg/dl and retest on the original and alternate analyzer generated 0. 8 mg/dl. No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1628664-2019-00313 |
| MDR Report Key | 8524692 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-04-17 |
| Date of Report | 2019-04-17 |
| Date Mfgr Received | 2019-03-28 |
| Device Manufacturer Date | 2019-01-28 |
| Date Added to Maude | 2019-04-17 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| 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 | 224667-512 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CREATININE |
| Generic Name | CREATININE |
| Product Code | CGX |
| Date Received | 2019-04-17 |
| Catalog Number | 03L81-22 |
| Lot Number | 55733UN18 |
| 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 | 2019-04-17 |