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 |