MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-10-07 for CLINICAL CHEMISTRY TOTAL BILIRUBIN 06L45-21 manufactured by Abbott Manufacturing Inc.
[89948720]
The customer indicated they were using lot numbers 50706uq01 and 51555uq07 during the timeframe of this event. It is unknown which lot generated the discrepant result. An evaluation is in process. A followup report will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
[89948721]
The account stated falsely depressed architect total bilirubin results were generated compared to reference lab and other hospital results. Data was provided for case 2: the patient is a three days old female. On (b)(6) 2017, the patient generated a total bilirubin of >17 mg/dl at another lab. On unknown date, the patient generated architect total bilirubin of 6. 6 mg/dl and the patient was discharged. On (b)(6) 2017, the patient generated a total bilirubin of >22. 5 mg/dl at another lab and was sent the emergency room. On (b)(6) 2017, the patient generated a total bilirubin of 21. 5 mg/dl at the emergency room and received photo therapy. The delay in photo therapy treatment did not harm or impact the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1628664-2017-00374 |
| MDR Report Key | 6927337 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-10-07 |
| Date of Report | 2018-01-15 |
| Date Mfgr Received | 2017-12-28 |
| Date Added to Maude | 2017-10-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | MQM |
| Date Received | 2017-10-07 |
| Catalog Number | 06L45-21 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT MANUFACTURING INC |
| Manufacturer Address | 1921 HURD DRIVE IRVING TX 75038 US 75038 |
| Brand Name | CLINICAL CHEMISTRY TOTAL BILIRUBIN |
| Generic Name | TOTAL BILIRUBIN REAGENT |
| Product Code | CIG |
| Date Received | 2017-10-07 |
| Catalog Number | 06L45-21 |
| 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 750383500 US 750383500 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-07 |