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 2017-07-06 for COBAS 6000 C501 MODULE 05860636001 manufactured by Roche Diagnostics.
[79151625]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[79151626]
The customer experienced issues with erratic qc results for ldhi2 lactate dehydrogenase since reagent lot 20254101 was put into use on (b)(6) 2017. Recalibration of the assay did not resolve the issue. On (b)(6) 2017, the customer repeated patient samples that were originally tested with the previous reagent lot number and the results were different. Of the data provided for four patient samples, only the results for three patient samples were discrepant. Patient 1: original result was 159 u/l, the retest result was 259 u/l. Patient 2: original result was 159 u/l, the retest result was 220 u/l. Patient 3: original result was 190 u/l, the retest result was 259 u/l. The original results had been reported outside the laboratory. The customer believed the retest results to be correct, but corrected reports were not issued. There was no adverse event. The previous reagent lot in use by the customer was 185970. The expiration date was requested but was not provided. The field service representative found there was a misadjusted gear pump pressure. He checked the sample and reagent probe alignments and the rinse mechanism nozzle dispense and evacuations which were ok. He adjusted the gear pump pressure. The customer ran precision testing and qc. All results met specifications. A query was performed for similar complaints and no abnormal trend identified. No past or new complaints of a similar nature on a like instrument occurred at this site in the past 12 months.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-01391 |
| MDR Report Key | 6689034 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-07-06 |
| Date of Report | 2017-07-06 |
| Date of Event | 2017-06-16 |
| Date Mfgr Received | 2017-06-16 |
| Date Added to Maude | 2017-07-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | HITACHI HIGH TECH CORP. |
| Manufacturer Street | 882 ICHIGE HITACHINAKA NA |
| Manufacturer City | IBARAKI 312-8504 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 312-8504 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS 6000 C501 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | CFH |
| Date Received | 2017-07-06 |
| Model Number | C501 |
| Catalog Number | 05860636001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 462500457 US 462500457 |
| Brand Name | COBAS 6000 C501 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-07-06 |
| Model Number | C501 |
| Catalog Number | 05860636001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2017-07-06 |