MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-20 for LACTATE DEHYDROGENASE 02P56-21 manufactured by Abbott Laboratories.
[126111325]
(b)(6) 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
[126111326]
The customer observed falsely elevated lactate dehydrogenase (ldh) results while using the clinical chemistry ldh assay. The customer provided the following results for 2 patients (reference range 125 to 220 u/l): patient 1: initial 303, retests: 238, 218, 300 and 295 u/l. Patient 2: initial 349, retests: 214, 205 and 206. No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1415939-2018-00152 |
| MDR Report Key | 7988301 |
| Date Received | 2018-10-20 |
| Date of Report | 2019-01-18 |
| Date Mfgr Received | 2019-01-08 |
| Device Manufacturer Date | 2018-05-01 |
| Date Added to Maude | 2018-10-20 |
| 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 LABORATORIES |
| Manufacturer Street | 100 ABBOTT PARK ROAD |
| Manufacturer City | ABBOTT PARK IL 600643500 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 600643500 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | LACTATE DEHYDROGENASE |
| Generic Name | LACTATE DEHYDROGENASE |
| Product Code | CFJ |
| Date Received | 2018-10-20 |
| Catalog Number | 02P56-21 |
| Lot Number | 99549UN18 |
| Device Expiration Date | 2019-02-19 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 100 ABBOTT PARK ROAD ABBOTT PARK IL 600643500 US 600643500 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-20 |