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 2018-07-12 for CLINICAL CHEMISTRY TOTAL BILIRUBIN 07P32-21 manufactured by Abbott Manufacturing Inc.
[114153298]
An evaluation is in process. A follow-up report will be submitted when the evaluation is complete. An evaluation is in process.
Patient Sequence No: 1, Text Type: N, H10
[114153299]
The customer observed falsely depressed results while using total bilirubin reagents. The following data was provided. Sid (b)(6) initial and repeat results read 0. 481 mg/dl (reported as less than 1. 50 mg/dl). Repeat using another analyzer 2. 67, 2. 74 mg/dl. No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1628664-2018-00268 |
| MDR Report Key | 7684141 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-07-12 |
| Date of Report | 2018-09-05 |
| Date of Event | 2018-06-18 |
| Date Mfgr Received | 2018-09-04 |
| Device Manufacturer Date | 2017-05-12 |
| Date Added to Maude | 2018-07-12 |
| 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 TOTAL BILIRUBIN |
| Generic Name | TOTAL BILIRUBIN REAGENT |
| Product Code | CIG |
| Date Received | 2018-07-12 |
| Catalog Number | 07P32-21 |
| Lot Number | 50973UQ03 |
| Device Expiration Date | 2018-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2018-07-12 |