MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2007-10-11 for ABBOTT CLINICAL CHEMISTRY TOTAL BILIRUBIN 6L45-20 manufactured by Abbott Manufacturing Inc..
[721834]
The customer stated, intermittent erratic low total bilirubin patient results have been generated on the architect c8000. Results of <0. 1 mg/dl have been reported and upon repeat are 0. 1 - 0. 6 mg/dl. A delta check flag was generated on the <0. 1 mg/dl results which prompted retesting. Corrected reports were issued. The customer did not have specific data, but identified five patients samples that exhibited erratic results. This report is for patient #1. No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
[8117285]
This is an initial report. An investigation is in process. A final report will be submitted when the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2018433-2007-00156 |
| MDR Report Key | 926683 |
| Report Source | 04 |
| Date Received | 2007-10-11 |
| Date of Report | 2007-09-14 |
| Date of Event | 2007-09-11 |
| Date Mfgr Received | 2007-09-14 |
| Date Added to Maude | 2007-12-07 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | DR. DAVID BARCH, D-09Y6, AP6C-2 |
| Manufacturer Street | 100 ABBOTT PARK ROAD |
| Manufacturer City | ABBOTT PARK IL 600646092 |
| Manufacturer Country | US |
| Manufacturer Postal | 600646092 |
| Manufacturer Phone | 8479379328 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ABBOTT CLINICAL CHEMISTRY TOTAL BILIRUBIN |
| Generic Name | QUANTITATION OF TOTAL BILIRUBIN |
| Product Code | JFM |
| Date Received | 2007-10-11 |
| Model Number | NA |
| Catalog Number | 6L45-20 |
| Lot Number | 52048HW00 |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 912469 |
| Manufacturer | ABBOTT MANUFACTURING INC. |
| Manufacturer Address | 820 MISSION STREET SOUTH PASADENA CA 91030 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-10-11 |