MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-01-24 for LDHI2 LACTATE DEHYDROGENASE 05169330190 manufactured by Roche Diagnostics.
[98305304]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[98305305]
The customer received questionable ldhi2 lactate dehydrogenase results for multiple patient samples after monthly maintenance was performed on cobas 8000 c 702 module serial number (b)(4). Most of the results were accompanied by data flags. Of the data provided for 10 patient samples, only the results for three patient samples were discrepant. Patient 1: initial result was 440 u/l and the repeat results from other cobas 8000 c 702 modules on (b)(6) 2018 were 215 u/l and 213 u/l. Patient 2: initial result was 376 u/l and the repeat results from other cobas 8000 c 702 modules were 188 u/l and 188 u/l. Patient 3: initial result was 398 u/l and the repeat results from other cobas 8000 c 702 modules were 240 u/l and 240 u/l. No erroneous result was reported outside of the laboratory. There was no adverse event. As no other enzymatic assays had issues, the customer suspected there was an issue with the reagent pack. The customer replaced the reagent pack which resolved the issue.
Patient Sequence No: 1, Text Type: D, B5
[132930559]
Follow up with the customer confirmed the issue was resolved by replacement of the reagent pack. A query was performed and found no past escalated complaints of this nature on any like instruments for the last 12 months at this site.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2018-00228 |
| MDR Report Key | 7216397 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-01-24 |
| Date of Report | 2018-01-30 |
| Date of Event | 2018-01-09 |
| Date Mfgr Received | 2018-01-11 |
| Date Added to Maude | 2018-01-24 |
| 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 | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | NA MICHAEL LESLIE |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175214343 |
| Manufacturer G1 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 116 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) 68305 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 68305 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LDHI2 LACTATE DEHYDROGENASE |
| Generic Name | LACTATE DEHYDROGENASE TEST SYSTEM |
| Product Code | CFJ |
| Date Received | 2018-01-24 |
| Model Number | NA |
| Catalog Number | 05169330190 |
| Lot Number | 280352 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-24 |