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 2017-04-10 for CLINICAL CHEMISTRY LACTATE DEHYDROGENASE 02P56-21 manufactured by Abbott Manufacturing Inc.
[72552996]
Lot/serial number was manufactured prior to udi compliance date; therefore, only a di is provided 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
[72552997]
The customer generated falsely elevated clinical chemistry ldh (lactate dehygrogenase) results. While comparing reagent kits the customer re-tested a specimen: they indicated the results went from 175 u/l to 225 u/l. The high result was released but was later corrected. No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
[75942252]
On april 18, 2017 the suspect medical device was updated to the architect c4000 analyzer based on the evaluation of the event. Further investigation of the customer issue included a review of the complaint data, part replacement, service history review, a search for similar complaints, and a review of labeling. Return material was not available. Abbott instructed the customer to replace the sample probe which resolved the issue. A review of the analyzer service history was performed and no contributing factor to the current event was found. Tracking and trending did not identify an adverse. Labeling was reviewed and found to be adequate. Based on the available information no product deficiency of the architect c4000 analyzer, list number 02p24, was identified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1628664-2017-00099 |
| MDR Report Key | 6475727 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-04-10 |
| Date of Report | 2017-05-15 |
| Date Mfgr Received | 2017-04-18 |
| Device Manufacturer Date | 2012-06-01 |
| Date Added to Maude | 2017-04-10 |
| 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 | 2017-04-10 |
| Catalog Number | 02P56-21 |
| Lot Number | 80712UN16 |
| 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 | 2017-04-10 |