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 2017-05-26 for COBAS 6000 C (501) MODULE C501 04745914001 manufactured by Roche Diagnostics.
[76133928]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[76133929]
The customer complained of an erroneous high result for 1 patient sample tested for dig digoxin (dig) on a cobas 6000 c (501) module. The initial dig result was 2. 37 ng/ml. This result was reported outside of the laboratory. The sample was repeated on a different c501 module and the result was 1. 75 ng/ml. The sample was repeated on the original c501 module used for the initial result and the result was 1. 75 ng/ml. The result of 1. 75 ng/ml was reported outside of the laboratory as a corrected result. The customer stated the original result was corrected before any action could have been taken since the original result was released during the evening and was corrected shortly afterwards. No adverse event occurred. The dig reagent lot number was 22798401 with an expiration date of 04/30/2018. The field service engineer (fse) visited the customer site where there was a possible sample probe issue. The fse cleaned the sample probe and verified alignment. Calibration and quality control results were within customer? S specification.
Patient Sequence No: 1, Text Type: D, B5
[76560394]
Upon follow up, the customer stated that this c501 module produces elevated dig results that repeat lower on the other module. The customer believes this has occurred since the most recent service visit. The customer could not provide any specific results related to this. The fse visited the customer site again where a low vacuum issue causing fluidic failure was identified. The fse replaced vacuum pump diaphragms and cleaned the main vacuum valves. Calibration and qc was performed and the results were within specifications.
Patient Sequence No: 1, Text Type: N, H10
[119990917]
The investigation determined that the low vacuum issue found by the fse was the root cause of the event. The result discrepancy appears to be due to carry over. A cell carry over can be caused by insufficient functioning of the vacuum. Reagent issues can be excluded since the repeat tests were performed under the same conditions.
Patient Sequence No: 1, Text Type: N, H10
[132591530]
The customer stated the issue has not recurred.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-01097 |
| MDR Report Key | 6593731 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-05-26 |
| Date of Report | 2017-08-03 |
| Date of Event | 2017-05-10 |
| Date Mfgr Received | 2017-05-10 |
| Date Added to Maude | 2017-05-26 |
| 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 C (501) MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | KXT |
| Date Received | 2017-05-26 |
| Model Number | C501 |
| Catalog Number | 04745914001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 C (501) MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-05-26 |
| Model Number | C501 |
| Catalog Number | 04745914001 |
| Lot Number | NA |
| 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 | 2017-05-26 |