MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-11-26 for CLINICAL CHEMISTRY TOTAL BILIRUBIN 06L45-41 manufactured by Abbott Manufacturing Inc.
[129328921]
Complete information for patient information, patient identifier, multiple = (b)(6). An evaluation is in process. A follow-up report will be submitted when the evaluation is complete. There was no further patient information provided by the customer.
Patient Sequence No: 1, Text Type: N, H10
[129328922]
The customer reported that they are observing falsely elevated total bilirubin on their architect compared to what their sister site is getting on both patient results and controls. The example results provided were for 2 adult patients: (b)(6) on (b)(6) 2018 =1. 9mg/dl (range = 0-1. 2mg/dl) / sample sent to arup = 1. 1 / previously on (b)(6) 2017 by roche = 1. 3; (b)(6) on (b)(6) 2018 = 2. 3mg/dl / sent to arup = 1. 4 / previously in 2017 = 0. 8 (unknown method). There was no reported impact to patient management.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1628664-2018-02032 |
| MDR Report Key | 8101461 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-11-26 |
| Date of Report | 2019-01-16 |
| Date of Event | 2018-09-04 |
| Date Mfgr Received | 2019-01-11 |
| Device Manufacturer Date | 2018-04-06 |
| Date Added to Maude | 2018-11-26 |
| 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 |
| Product Code | CIG |
| Date Received | 2018-11-26 |
| Catalog Number | 06L45-41 |
| Lot Number | 52656UQ02 |
| Device Expiration Date | 2019-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2018-11-26 |