MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-11-16 for CLINICAL CHEMISTRY CREATININE 03L81-22 manufactured by Abbott Manufacturing Inc.
[129182305]
An evaluation is in process. A follow-up report will be submitted when the evaluation is complete. An evaluation is in process.
Patient Sequence No: 1, Text Type: N, H10
[129182306]
The customer observed falsely elevated results while using clinical chemistry creatinine reagents. The following data was provided. The customer uses normal range 0. 5 to 1. 4 mg/dl. Sid (b)(6) initial 2. 8 mg/dl, repeat 0. 89, 0. 92 mg/dl. A precision study using the patient specimen showed values from 0. 86 to 0. 90 mg/dl. Due to the first elevated value, the patient was transferred to another hospital under suspicion of renal failure. No treatment was reported for the patient. During testing at the other hospital, the patient creatinine value was normal, however no specific value or method were provided. No adverse impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 1628664-2018-02014 |
MDR Report Key | 8081557 |
Report Source | HEALTH PROFESSIONAL |
Date Received | 2018-11-16 |
Date of Report | 2019-02-13 |
Date of Event | 2018-10-21 |
Date Mfgr Received | 2019-02-06 |
Device Manufacturer Date | 2018-05-02 |
Date Added to Maude | 2018-11-16 |
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 | 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 CREATININE |
Generic Name | CREATININE |
Product Code | CGX |
Date Received | 2018-11-16 |
Catalog Number | 03L81-22 |
Lot Number | 93990UN18 |
Device Expiration Date | 2019-09-01 |
Operator | HEALTH PROFESSIONAL |
Device Availability | * |
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 | 2018-11-16 |