MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2018-09-25 for CLINICAL CHEMISTRY CREATININE 03L81-32 manufactured by Abbott Manufacturing Inc.
[121725435]
An evaluation is in process. A follow-up report will be submitted when the evaluation is complete. (b)(6). An evaluation is in-process.
Patient Sequence No: 1, Text Type: N, H10
[121725436]
The customer observed a falsely elevated creatinine result while using clinical chemistry creatinine assay. The customer provided the following data (provided cutoff value: 09. Mg/dl): on (b)(6) 2018: initial: 3. 10 mg/dl, retest 1. 05 mg/dl, retested on a second analyzer: 1. 07 mg/dl. There was no adverse impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1628664-2018-01911 |
| MDR Report Key | 7906425 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-09-25 |
| Date of Report | 2019-01-02 |
| Date of Event | 2018-09-04 |
| Date Mfgr Received | 2018-12-26 |
| Device Manufacturer Date | 2018-03-16 |
| Date Added to Maude | 2018-09-25 |
| 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 | CLINICAL CHEMISTRY CREATININE |
| Generic Name | CREATININE |
| Product Code | CGX |
| Date Received | 2018-09-25 |
| Catalog Number | 03L81-32 |
| Lot Number | UNKNOWN |
| Device Expiration Date | 2019-11-05 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2018-09-25 |