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 2016-09-09 for COBAS 6000 C501 MODULE 05860636001 manufactured by Roche Diagnostics.
[54327124]
Patient Sequence No: 1, Text Type: N, H10
[54327125]
The customer stated that they received an erroneous result for one patient sample tested for nh3l ammonia (nh3) on a c501 analyzer. The sample initially resulted as 461. 0 umol/l and this value was reported outside of the laboratory to a physician. The patient was treated based on the initial result, but no details could be provided regarding the treatment that was provided. A second sample was collected from the patient for monitoring and this sample resulted as 28. 9 umol/l accompanied by a data flag on (b)(6) 2016. The second sample was diluted manually at a times three dilution, resulting with a raw value of 13. 5 on (b)(6) 2016. When accounting for the dilution factor, the diluted sample resulted with a final value of 40. 5 umol/l. The physician questioned the value obtained with the original sample since the result from the second sample was normal. The original sample was repeated on (b)(6) 2016, resulting as 30. 9 umol/l accompanied by a data flag. The original sample was repeated a second time, resulting as 50. 8 umol/l. A third sample was also collected from the patient and tested on (b)(6) 2016, resulting as 34. 8 umol/l accompanied by a data flag. The third sample was diluted manually at a times three dilution, resulting with a raw value of 12. 0 on (b)(6) 2016. When accounting for the dilution factor, the diluted sample resulted with a final value of 36. 0 umol/l. The repeat analysis of the original sample and results from the second and third samples were believed to be correct. It was asked, but it is not known if the patient was adversely affected due to receiving treatment. No adverse events were alleged to have occurred with this patient. The nh3 reagent lot number and expiration date were asked for, but not provided. The customer stated that one level of control was outside of range prior to the event. The field service representative could not find a cause for the event. He checked the operation of the instrument. The customer ran precision studies, calibration, and quality controls; all tests passed. During investigations, it was stated that the issue is likely related to pre-analytic sample handling since the affected sample was said to be only 1/4 full.
Patient Sequence No: 1, Text Type: D, B5
[56571407]
A specific root cause could not be determined with the information provided for investigation. Additional information for further investigation was requested but not provided. Since the customer stated that the tube was only 1/4 full, a pre-analytic sample handling issue seems likely. No other patient results were questioned as values matched previous results. The product was found to meet specifications. Ammonia concentrations can increase in-vitro due to break down of nitrogen-containing plasma components. This may occur due to situations such as incorrect sample storage conditions or ammonia contamination from the environment.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-01342 |
| MDR Report Key | 5939598 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-09-09 |
| Date of Report | 2016-09-29 |
| Date of Event | 2016-08-23 |
| Date Mfgr Received | 2016-08-24 |
| Date Added to Maude | 2016-09-09 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | JIF |
| Date Received | 2016-09-09 |
| Model Number | C501 |
| Catalog Number | 05860636001 |
| 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 C501 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2016-09-09 |
| Model Number | C501 |
| Catalog Number | 05860636001 |
| 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 | 2016-09-09 |