MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-05-21 for CLINICAL CHEMISTRY LACTATE DEHYDROGENASE 02P56-21 manufactured by Abbott Manufacturing Inc.
[109121199]
An evaluation is in process. A follow-up report will be submitted when the evaluation is complete. Patient information: (b)(6), (b)(6) year old male.
Patient Sequence No: 1, Text Type: N, H10
[109121200]
The customer reported falsely elevated and inconsistent architect lactate dehydrogenase (ldh) results for two patients. Sample id (b)(6) from a (b)(6) year old male patient generated results ranging from 196 to 655 u/l for the patient's plasma sample and 281 u/l with the serum sample. A 196 u/l was reported based on previous results. The samples were further tested at quest generating results for the plasma sample of 587 and serum sample 234 (uom and method not provided). Sample id (b)(6) from a (b)(6) year old male patient generated results ranging from 187 to 438 u/l for the plasma sample and 177 u/l for the serum sample. A 187 u/l was reported based on previous results. The samples were further tested at (b)(6) lab generating results of 255 for the plasma and 234 for the serum (uom and method not provided). The customer indicated the normal range is 125 to 220 u/l. No adverse impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1628664-2018-00198 |
| MDR Report Key | 7529849 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-05-21 |
| Date of Report | 2018-06-15 |
| Date of Event | 2018-05-01 |
| Date Mfgr Received | 2018-06-12 |
| Device Manufacturer Date | 2017-10-30 |
| Date Added to Maude | 2018-05-21 |
| 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 | 2018-05-21 |
| Catalog Number | 02P56-21 |
| Lot Number | 60062UN17 |
| Device Expiration Date | 2018-07-10 |
| 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 | 2018-05-21 |