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 2019-03-05 for CLINICAL CHEMISTRY TOTAL BILIRUBIN 06L45-21 manufactured by Abbott Manufacturing Inc.
[137947014]
An evaluation is in process. A follow-up report will be submitted when the evaluation is complete. There is no further patient information provided due to privacy issues.
Patient Sequence No: 1, Text Type: N, H10
[137947015]
The customer reported falsely elevated total bili on one neonate patient ((b)(6)) from the architect analyzer. The results provided were: initial >428umol/l / repeated = >428umol/l. The patient was treated with phototherapy. The sample was tested on the alinity analyzer and the result = 179. 6umol/l (<48hrs full term = <171. 0mumol/l). There was no reported adverse impact to the patient due to the phototherapy.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 1628664-2019-00179 |
MDR Report Key | 8392175 |
Report Source | FOREIGN,HEALTH PROFESSIONAL |
Date Received | 2019-03-05 |
Date of Report | 2019-05-13 |
Date Mfgr Received | 2019-04-22 |
Device Manufacturer Date | 2018-11-02 |
Date Added to Maude | 2019-03-05 |
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 |
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 | 2019-03-05 |
Catalog Number | 06L45-21 |
Lot Number | 53599UQ08 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | N |
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 | 1. Other | 2019-03-05 |