MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-11-02 for CLINICAL CHEMISTRY TOTAL BILIRUBIN 06L45-41 manufactured by Abbott Manufacturing Inc.
[127887661]
An evaluation is in process. A follow-up report will be submitted when the evaluation is complete. Mdr number 1628664-2018-01983 has been submitted for this issue that also involves the architect c8000 analyzer. An evaluation is in process.
Patient Sequence No: 1, Text Type: N, H10
[127887662]
The customer observed falsely depressed results for a pediatric patient while using clinical chemistry total bilirubin reagents with the architect c8000 analyzer. The following data was provided. The customer uses normal range less than or equal to 1. 9 ng/ml. Sid (b)(4), initial 0. 7 ng/dl, repeat 6. 8, 6. 8 ng/dl. No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1628664-2018-01982 |
| MDR Report Key | 8034914 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-11-02 |
| Date of Report | 2018-11-19 |
| Date of Event | 2018-10-08 |
| Date Mfgr Received | 2018-11-13 |
| Date Added to Maude | 2018-11-02 |
| 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 | 2018-11-02 |
| Catalog Number | 06L45-41 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2018-11-02 |