MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-12-04 for CLINICAL CHEMISTRY TOTAL BILIRUBIN 06L45-21 manufactured by Abbott Manufacturing Inc.
[129786717]
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
[129786718]
The customer observed falsely depressed results while using clinical chemistry total bilirubin reagents. The following data was provided for the same patient. Specimen 2 : tested (b)(6) 2018 11:13 p. M. 2. 3 mg/dl, repeated (b)(6) 2018 using the same analyzer 12. 0 mg/dl, using a different analyzer 11. 3 mg/dl. Previous and subsequent specimens were higher. Specimen 1 tested (b)(6) 2018 11:33 a. M. 9. 4 mg/dl ; specimen 3 tested (b)(6) 2018 06:33 a. M. 12. 8 mg/dl ; specimen 4 tested (b)(6) 2018 07:18 a. M. 13. 4 mg/dl. No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1628664-2018-02102 |
| MDR Report Key | 8129890 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-12-04 |
| Date of Report | 2019-01-15 |
| Date of Event | 2018-10-13 |
| Date Mfgr Received | 2019-01-11 |
| Device Manufacturer Date | 2018-07-27 |
| Date Added to Maude | 2018-12-04 |
| 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 | 2018-12-04 |
| Catalog Number | 06L45-21 |
| Lot Number | 53066UQ05 |
| Device Expiration Date | 2019-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2018-12-04 |