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 2017-11-02 for CLINICAL CHEMISTRY LACTATE DEHYDROGENASE 2P56-21 02P56-21 manufactured by Abbott Manufacturing Inc.
[91460850]
An abbott field technician visited the customer site to review the issue with the customer. The reagent was replaced and placed in a different position on the analyzer. The water quality was checked and found to be acceptable. The sample diluent was also replaced and the customer informed to replace daily. Subsequent instrument operations and test results were acceptable. A review of complaint tracking and trending metrics was performed and identified no adverse trends in conjunction with the complaint issue currently under evaluation. No returns were made available from the customer site. Instrument logs and history files were reviewed as stored in the architect c16000 analyzer for the clin chem ldh assay. The assay curve pattern was unremarkable and similar to other curves. From (b)(6) 2017, sixty instances of aspiration error codes were logged along with twenty-four instances of incomplete cuvette washing error codes. Sample handling and/or sample integrity issues cannot be ruled out as possible causes of the customer issue as well as incomplete instrument maintenance. The architect clinical chemistry ldh assay package insert and the architect operations manual contains information to address the current customer issue. Based on the available information from the customer site and the results of this evaluation, there is no evidence to reasonably suggest a systemic issue or product deficiency exists.
Patient Sequence No: 1, Text Type: N, H10
[91460851]
On (b)(6) 2017, the following architect clin chem assay results were generated on an architect c16000 analyzer: (b)(6): initial result of 237 u/l that retested at 191 u/l. (b)(6): initial result of 279 u/l that retested at 207 u/l. The customer uses a normal reference range of 125 to 220 u/l. The customer will begin testing all samples for ldh in duplicate. No suspect results were reported from the lab. There is no impact to patient care reported. A service call was initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1628664-2017-00414 |
| MDR Report Key | 6995744 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-11-02 |
| Date of Report | 2017-11-02 |
| Date of Event | 2017-10-16 |
| Date Mfgr Received | 2017-10-19 |
| Device Manufacturer Date | 2017-03-21 |
| Date Added to Maude | 2017-11-02 |
| 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 LACTATE DEHYDROGENASE |
| Generic Name | LACTATE DEHYDROGENASE |
| Product Code | CFJ |
| Date Received | 2017-11-02 |
| Model Number | 2P56-21 |
| Catalog Number | 02P56-21 |
| Lot Number | 36251UN17 |
| Device Expiration Date | 2018-01-06 |
| 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 | 2017-11-02 |