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 2017-03-02 for CLINICAL CHEMISTRY LACTATE DEHYDROGENASE 02P56-21 manufactured by Abbott Manufacturing Inc.
[68981670]
An evaluation is in process. A follow-up report will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
[68981671]
The customer reports the following results for patient samples tested with the architect clin chem ldh assay: sid l29006814: initial result of 427 u/l with retest at 301 u/l. Sid l290010156: initial result of 407 u/l with restest at 325 u/l. Sid l290033852 : initial result of 304 u/l with retests at 182. 90, 188. 35 and on another analyzer in the lab at 173. 36 and 240. 61 u/l. Sid l290033823: initial result of 317 u/l with retests at 255. 61 and 268 u/l. Sid l290033875: no initial test results provided, but retest result of 200, 220 u/l are documented. Reference is also made to an undisclosed publication the customer referenced, which stated that an ldh decrease in results from approximately 700 u/l to 200 u/l is significant. The customer believes that the higher results are falsely elevated. There is no impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5
[71757696]
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 for this evaluation. The clin chem lactate dehydrogenase (ldh) assay package insert and the architect system operations manual provide information to address the current customer issue. Based on the available information from the customer site and from the results of this evaluation, there is evidence to reasonably suggest a product malfunction occurred. However, no systemic issue or product deficiency was identified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1628664-2017-00051 |
| MDR Report Key | 6371938 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-03-02 |
| Date of Report | 2017-03-29 |
| Date of Event | 2017-02-06 |
| Date Mfgr Received | 2017-03-28 |
| Device Manufacturer Date | 2016-10-10 |
| Date Added to Maude | 2017-03-02 |
| 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 | 2017-03-02 |
| Catalog Number | 02P56-21 |
| Lot Number | 89174UN16 |
| Device Expiration Date | 2017-08-02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2017-03-02 |