MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2018-10-30 for CLINICAL CHEMISTRY GLUCOSE 03L82-21 manufactured by Abbott Manufacturing Inc.
[126544594]
A review for any complaints against glucose reagent lot 51839uq09 was performed, and no other complaints or trends were identified. Return testing was not completed as returns were not available. The field service engineer inspected the instrument and identified a rusty wire in the incubator, and water pressure to the probe wash cups and mixer was low. The o-rings and diaphram pump parts were replaced proactively. After the repairs were performed, assay performance was checked and was acceptable. The instrument result log during the time frame was reviewed to confirm the customer's report. The samples with the glucose values attributed to the complaint were not located. In addition, the sample ids reported by the customer were not located in the log. The actual printouts from the customer were requested, but were not available. A review of labeling concluded sufficient information is provided to detect, troubleshoot and resolve results related problems, should they occur. Erratic results and/or poor precision is addressed in the operations manual with the most likely causes to be either sample preparation or instrument hardware. Manufacturing documentation for glucose, list number 3l82 was reviewed and no contributing factors to the complaint could be identified. Based on this investigation no product deficiency was identified for glucose reagent, lot 51839uq09. This issue was previously reported under mdr number (1415939-2018-00072) associated with the incorrect manufacturing site.
Patient Sequence No: 1, Text Type: N, H10
[126544595]
The customer reported a falsely elevated glucose result on one patient. The results provided were: initial = 360mg/dl / repeat with a new sample was normal (approximately 90mg/dl). There was no reported impact to patient management.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1628664-2018-01981 |
| MDR Report Key | 8020374 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-10-30 |
| Date of Report | 2018-10-30 |
| Date of Event | 2018-03-14 |
| Date Mfgr Received | 2018-10-30 |
| Device Manufacturer Date | 2017-11-01 |
| Date Added to Maude | 2018-10-30 |
| 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 | 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 GLUCOSE |
| Generic Name | GLUCOSE |
| Product Code | CFR |
| Date Received | 2018-10-30 |
| Catalog Number | 03L82-21 |
| Lot Number | 51839UQ09 |
| Device Expiration Date | 2018-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2018-10-30 |