MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-01-14 for CLINICAL CHEMISTRY CREATININE 03L81-22 manufactured by Abbott Manufacturing Inc.
[134061744]
Further investigation of the customer issue included a review of complaint test, historical complaints and product labeling. No adverse trend was identified for the customer's issue. Review of the complaint activity determined that there was no increase identified. Labeling was reviewed and found to be adequate. Based on all available information and abbott diagnostic's complaint investigation, no product deficiency was identified. Note: this information was previously reported in manufacturer report 1415939-2018-00164 against the incorrect manufacturing site.
Patient Sequence No: 1, Text Type: N, H10
[134061745]
The customer observed multiple falsely elevated architect creatinine results from a patient sample. The initial result was 6. 72 mg/dl and repeat results (same instrument) were 6. 72 and 6. 63 mg/dl. The customer uses a reference range of 0. 57-1. 25 mg/dl. As a result, the patient was sent for a redraw and repeat testing was normal (no specific result provided). No other impact to patient management was reported. The customer reported there were no issues with sample collection/handling nor with sample integrity and that other assays were performed on the same sample without any issue. An aliquot of the original sample was sent to (b)(6) for testing (cobas 710 instrument, creatinine jaffe method) and yielded a result of 2. 646. Additional testing (ex. Bun) correlated with the creatinine redraw normal result, patient history and previously reported results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1628664-2019-00023 |
| MDR Report Key | 8245463 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-01-14 |
| Date of Report | 2019-01-14 |
| Date of Event | 2018-11-06 |
| Date Mfgr Received | 2018-12-16 |
| Device Manufacturer Date | 2018-01-01 |
| Date Added to Maude | 2019-01-14 |
| 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 | 2019-01-14 |
| Catalog Number | 03L81-22 |
| Lot Number | 75410UN17 |
| Device Expiration Date | 2019-05-13 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2019-01-14 |