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 2018-02-12 for CLIN CHEM LDH 02P56-21 manufactured by Abbott Manufacturing Inc.
[100137204]
An evaluation is in process. A follow-up report will be submitted when the evaluation is complete. Additional information. Patient information. Patient identifier - multiple = (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[100137205]
The customer reported falsely elevated/erratic ldh results generated on the architect analyzer on 10 patients. The discrepant results provided were: (b)(6) = 262u/l / 178 / 215; (b)(6) =237 / 301 / 256; (b)(6) =235 / 208; (b)(6) 213 / 231; (b)(6) = 222ul / 254 / 216 / 241; (b)(6) = 250 / 179 / 217 / 267; (b)(6) = 165 / 265; (b)(6) =233 / 215; (b)(6) = 220 / 265 / 252; (b)(6) = 180 / 226. There was no reported impact to patient management. There was no additional patient information provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1628664-2018-00059 |
| MDR Report Key | 7263408 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-02-12 |
| Date of Report | 2018-02-21 |
| Date of Event | 2018-01-18 |
| Date Mfgr Received | 2018-02-14 |
| Device Manufacturer Date | 2017-09-19 |
| Date Added to Maude | 2018-02-12 |
| 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 | CLIN CHEM LDH |
| Generic Name | LACTATE DEHYDROGENASE |
| Product Code | CFJ |
| Date Received | 2018-02-12 |
| Catalog Number | 02P56-21 |
| Lot Number | 45139UN17 |
| Device Expiration Date | 2018-07-10 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2018-02-12 |