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 2018-02-08 for CLINICAL CHEMISTRY LACTATE DEHYDROGENASE 02P56-21 manufactured by Abbott Manufacturing Inc.
[99991420]
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
[99991421]
The customer reported falsely elevated and inconsistent architect lactate dehydrogenase results. The customer provided the following discrepant results. Sample id (b)(6) generated 226 and 180 u/ml. Sample id (b)(6) generated 262, 215 and 178 u/ml. Sample id (b)(6) generated 235 and 208 u/ml. Sample id (b)(6) generated 231 and 213 u/ml. Sample id (b)(6) generated 237 and 202 u/ml. Sample id (b)(6) generated 223 and 218 u/ml. Sample id (b)(6) generated 254, 241, 222 and 216 u/ml. Sample id (b)(6) generated 267, 250, 217 and 179 u/ml. Sample id (b)(6) generated 226, 202 and 216 u/ml. Sample id (b)(6) generated 232, 203 and 202 u/ml. Sample id (b)(6) generated 226 and 188 u/ml. Sample id (b)(6) generated 221 and 188 u/ml. Sample id (b)(6) generated 265 and 165 u/ml. Sample id (b)(6) generated 223 and 202 u/ml. Sample id (b)(6) generated 233 and 215 u/ml. Sample id (b)(6) generated 265, 252 and 220 u/ml. Sample id (b)(6) generated 229 and 220 u/ml. No specific patient information was provided and no adverse impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1628664-2018-00056 |
| MDR Report Key | 7252986 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-02-08 |
| Date of Report | 2018-02-23 |
| Date of Event | 2018-01-21 |
| Date Mfgr Received | 2018-02-14 |
| Device Manufacturer Date | 2017-09-19 |
| Date Added to Maude | 2018-02-08 |
| 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 | 2018-02-08 |
| Catalog Number | 02P56-21 |
| Lot Number | 45139UN17 |
| Device Expiration Date | 2018-07-10 |
| 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 MANUFACTURING INC |
| Manufacturer Address | 1921 HURD DRIVE IRVING TX 75038 US 75038 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-08 |