MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-10-29 for CLINICAL CHEMISTRY TOTAL BILIRUBIN 06L45-21 manufactured by Abbott Manufacturing Inc.
[126663869]
Evaluation of the customer issue included a complaint text review, a search for similar complaints, device history review, and labeling review. The product was not returned. No adverse trend was identified for the customer issue. Device history review did not identify any issues that may have caused the customer issue. Labeling was reviewed and found to be adequate. Based on all available information and abbott diagnostics evaluation, no systemic issue was identified and no product deficiency was found.
Patient Sequence No: 1, Text Type: N, H10
[126663870]
The customer observed falsely depressed results while using clinical chemistry total bilirubin reagents. The following data was provided for the same newborn patient. The customer uses normal range 0. 3 to 1. 5 mg/dl and critical value greater than 14. 9 mg/dl. Sid: (b)(6). Specimen drawn on (b)(6) 2018 at 30 hours of life was lower, 0. 4 mg/dl. Previous and subsequent specimen results for the same patient were higher. Specimen drawn on (b)(6) 2018, at 3 hours of life, 3. 5 mg/dl. Specimen drawn on (b)(6) 2018 at 29 hours of life) initial 29. 0 mg/dl. Specimens drawn on (b)(6) 2018 12. 0, 13. 0 mg/dl. Specimen drawn on (b)(6) 2018 10. 7 mg/dl. Advance br2 method was higher for the specimen drawn on (b)(6) 2018 at 30 hours (8. 6 mg/dl). No adverse impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1628664-2018-01978 |
| MDR Report Key | 8016271 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-10-29 |
| Date of Report | 2018-10-29 |
| Date of Event | 2018-10-01 |
| Date Mfgr Received | 2018-10-10 |
| Device Manufacturer Date | 2018-07-27 |
| Date Added to Maude | 2018-10-29 |
| 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 | 2018-10-29 |
| Catalog Number | 06L45-21 |
| Lot Number | 53066UQ05 |
| Device Expiration Date | 2019-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2018-10-29 |