MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-10-10 for COBAS 6000 C501 MODULE 05860636001 manufactured by Roche Diagnostics.
[2349540]
The customer received questionable ammonia results on their c501 analyzer. All samples tested were aliquots from the primary tubes. The patient's initial aliquot's ammonia result was 304 mmol/l accompanied by a data flag. This result was reported outside the laboratory. The patient's second aliquot's ammonia result was 258 mmol/l accompanied by a data flag. The patient's third aliquot, run on another c501 (serial number (b)(4)) (c2), had an ammonia result of 101 mmol/l accompanied by a data flag. The patient's fourth aliquot, run on the original c501 (c1), had an ammonia result of 100 mmol/l. The customer questioned the ammonia results which were above the laboratory's reference range and asked the nurse to have a new sample drawn. The first aliquot from the second sample was run on c1 and had an ammonia result of 107 mmol/l accompanied by a data flag. The second aliquot from the second sample was run on c1 had an ammonia result of 29 mmol/l. The third aliquot from the second sample was run on c2 and had an ammonia result of 29 mmol/l. The fourth aliquot from the second sample was run in c2 and had an ammonia result of 26 mmol/l. The customer believed the second sample's result of 29 or 26 mmol/l to be correct, but only the initial result of 304 mmol/l was reported. The patient was not admitted to the hospital based on the reported result. The patient did not have treatment given or withheld based on the reported result. There were no adverse affects from this event. The ammonia reagent lot number was 64083501 and the expiration date was 09/30/2012. The field service representative found contaminated sample lines on the analyzer. He cleaned the sample and reagent lines with chlorine dioxide. He cleaned the water container. He performed a check test and a precision test with passing results. The system was operational.
Patient Sequence No: 1, Text Type: D, B5
[9307042]
.
Patient Sequence No: 1, Text Type: N, H10
[9672306]
A specific root cause could not be identified. Critical information was not provided for further investigation. Based on the information provided, a possible explanation might be fluctuating contamination of the sample aliquots by erythrocytes. Erythrocytes contain significant ammounts of ammonia. This additional ammonia input could explain the higher recoveries in some of the aliquots. No adverse event was reported.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2011-05314 |
| MDR Report Key | 2284042 |
| Report Source | 05,06 |
| Date Received | 2011-10-10 |
| Date of Report | 2012-03-09 |
| Date of Event | 2011-09-26 |
| Date Mfgr Received | 2011-09-26 |
| Date Added to Maude | 2011-10-10 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | NA JENNIFER WOLFGRAM |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175217008 |
| Manufacturer G1 | HITACHI HIGH TECH CORP. |
| Manufacturer Street | 882 ICHIGE HITACHINAKA NA |
| Manufacturer City | IBARAKI 312-8504 |
| 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 | 2011-10-10 |
| 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 | 2011-10-10 |