MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-05-20 for TOTAL BILIRUBIN 06L45-21 manufactured by Abbott Manufacturing Inc.
[145516243]
Complete information for patient information, patient identifier: multiple = (b)(6). All available patient information was included. Additional patient details are not available. An evaluation is in process. A follow up report will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
[145516244]
The customer reported falsely elevated total bilirubin results were generated for neonates while using the architect c461216 analyzer. The following results were provided: sid: (b)(6) - architect: 17. 8 mg/dl; alternate method: 13. 9 mg/dl (% shift = 28%). Sid: (b)(6) - architect: 10. 2 mg/dl; alternate method: 8. 3 mg/dl (% shift = 22. 9%). The customer further stated that sid: (b)(6) generated an architect result of 15. 2 mg/dl, with a alternate method result of 12. 3 mg/dl (% shift = 23. 6%); however, the customer was not sure if the architect result was generated on the c461216 or the c401829 analyzer. The customer was utilizing a critical cut off of >/= 17 mg/dl. No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1628664-2019-00390 |
| MDR Report Key | 8623836 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-05-20 |
| Date of Report | 2019-07-23 |
| Date of Event | 2019-03-08 |
| Date Mfgr Received | 2019-07-14 |
| Device Manufacturer Date | 2018-11-16 |
| Date Added to Maude | 2019-05-20 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CHRISTIAN LEE |
| Manufacturer Street | 100 ABBOTT PARK ROAD DEPT 09B9, BLDG CP01-3 |
| Manufacturer City | ABBOTT PARK IL 600643537 |
| Manufacturer Country | US |
| Manufacturer Postal | 600643537 |
| Manufacturer Phone | 224668-294 |
| 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 | TOTAL BILIRUBIN |
| Generic Name | TOTAL BILIRUBIN REAGENT |
| Product Code | CIG |
| Date Received | 2019-05-20 |
| Catalog Number | 06L45-21 |
| Lot Number | 53810UQ09 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2019-05-20 |