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 2015-10-12 for COBAS 6000 C501 MODULE 05860636001 manufactured by Roche Diagnostics.
[28043737]
Patient Sequence No: 1, Text Type: N, H10
[28043738]
The customer reported that they received an erroneous result for one patient sample tested for ethanol on a c501 analyzer. The patient was being tested as part of a drug screen. The testing is part of a monthly program for employment conditional to the ethanol results. The patient had been negative for ethanol for the prior 11 months. The sample initially resulted as 28 mg/dl and this result was reported outside of the laboratory as 0. 03 g/dl. The patient came back to the customer site for a sample recollection that same day. The new sample resulted as 10 mg/dl accompanied by a data flag. The original sample and new sample were then both repeated with both resulting as 10 mg/dl accompanied by a data flag. It was noted that the original sample was sitting on board the analyzer and open prior to being repeated. The original sample was repeated approximately one and a half hours after being initially run. It was explained to the customer that it was possible for evaporation of the sample to cause lower results. Seven additional repeats were also performed on (b)(6) 2015, but it is not clear if each repeat result was from the original sample or the new sample. A clarification has been requested. All additional repeats resulted as 10 mg/dl accompanied by a data flag. The customer later stated that there was an additional non-opened tube that had been collected from the patient at the same time as the original sample. This sample was tested on (b)(6) 2015 and it resulted as "
[29088146]
It has been clarified that the original sample was repeated three times on (b)(6) 2015, and each repeat resulted as 10 mg/dl accompanied by a data flag. It has been clarified that the new sample was repeated three times on (b)(6) 2015, and each repeat resulted as 10 mg/dl accompanied by a data flag. Investigations have determined that a general issue with the instrument or reagent is not likely. A specific root cause for the issue could not be determined based on the provided information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2015-04308 |
| MDR Report Key | 5144167 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2015-10-12 |
| Date of Report | 2015-10-21 |
| Date of Event | 2015-09-17 |
| Date Mfgr Received | 2015-09-18 |
| Date Added to Maude | 2015-10-12 |
| 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 |
| 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 | DIC |
| Date Received | 2015-10-12 |
| Model Number | NA |
| 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 46250 US 46250 |
| Brand Name | COBAS 6000 C501 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2015-10-12 |
| Model Number | NA |
| 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 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-10-12 |