MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-06 for LACTATE DEHYDROGENASE 02P56-21 manufactured by Abbott Manufacturing Inc.
[54549140]
Further investigation of the customer issue included a review of the complaint text, in-house testing, instrument log review, a search for similar complaints, and a review of labeling. Return material was made available. In house testing protocol was executed; the assay files for the reagent lot number was successfully calibrated and each validity control replicate generated was within the established ranges. It was determined the reagent lot is performing acceptably. The instrument logs did indicated that instrument error messages were generated on the customer analyzer. The error could indicate the presence of bubbles, foam or fibrin in the sample. Tracking and trending did not identify an adverse trend. Labeling was reviewed and found to be adequate. Based on the available information no malfunction and no product deficiency of the clinical chemistry lactate dehydrgenase assay, reagent list number 02p56-21 , lot number 25802un16 , were identified.
Patient Sequence No: 1, Text Type: N, H10
[54549141]
The customer generated falsely elevated clinical chemistry ldh (lactate dehygrogenase) results. The customer indicated that a pregnant woman, (b)(6) weeks gestation, was admitted to the hospital and had her labor induced. The customer documented that the patient had hypertension and positive protein results in conjunction with the elevated ldh result. The customer provided the following ldh results: (b)(6) 2016: initial 1063 u/l, the patient was redrawn 12 hours later, (b)(6) 2016: 142. 4 u/l. The original specimen was retested on (b)(6) 2016: 363. 0 and 303 u/l it is unknown whether the patient had pre-eclampsia therefore the induction may have been unnecessary. The infant is doing well and there were no complications documented regarding the delivery.
Patient Sequence No: 1, Text Type: D, B5
[74623763]
The device evaluation was reassessed and concluded that a malfunction occurred. However, no systemic issue or product deficiency was identified for the clinical chemistry lactate dehydrgenase assay, reagent list number 02p56-21, lot number 25802un16.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1628664-2016-00229 |
| MDR Report Key | 5930736 |
| Date Received | 2016-09-06 |
| Date of Report | 2017-04-23 |
| Date of Event | 2016-08-03 |
| Date Mfgr Received | 2017-04-17 |
| Device Manufacturer Date | 2016-04-01 |
| Date Added to Maude | 2016-09-06 |
| 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 | LACTATE DEHYDROGENASE |
| Generic Name | LACTATE DEHYDROGENASE |
| Product Code | CFJ |
| Date Received | 2016-09-06 |
| Catalog Number | 02P56-21 |
| Lot Number | 25802UN16 |
| Device Expiration Date | 2017-02-05 |
| 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 | 1. Other | 2016-09-06 |