MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-05-16 for TOTAL BILIRUBIN 06L45-21 manufactured by Abbott Manufacturing Inc.
[145379392]
This mdr was previously submitted under the incorrect manufacturing site in mfr 1415939-2019-00027. This mdr is being submitted to correct the manufacturing site to abbott manufacturing, (b)(4). All available patient information was included. Additional patient details are not available. An evaluation is in process. A follow up report will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
[145379393]
The customer reported falsely elevated total bilirubin results were generated for a patient on the architect analyzer. The customer reported sid (b)(6) generated an initial result of 17 mg/dl, with a retest result of 5. 06 mg/dl (in house range 0. 10 - 1. 20 mg/dl). The customer further stated that the sample generated a result of 5. 1 mg/dl on a second analyzer. No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1628664-2019-00386 |
| MDR Report Key | 8616750 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-05-16 |
| Date of Report | 2019-07-02 |
| Date of Event | 2019-04-10 |
| Date Mfgr Received | 2019-07-01 |
| Device Manufacturer Date | 2018-12-06 |
| Date Added to Maude | 2019-05-16 |
| 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 | TOTAL BILIRUBIN |
| Generic Name | TOTAL BILIRUBIN REAGENT |
| Product Code | CIG |
| Date Received | 2019-05-16 |
| Catalog Number | 06L45-21 |
| Lot Number | 53990UQ10 |
| 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 | 2019-05-16 |