MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-08-22 for COBAS 8000 C (701) MODULE C701 05641489001 manufactured by Roche Diagnostics.
[83218796]
(b)(4). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[83218797]
The customer obtained a questionable low test result for one patient sample using the ureal urea/bun (bun) on the cobas 8000 c (701) module. The initial result was released outside of the laboratory. All results are in units of mg/dl. No data flags or alarms occurred with the results. The initial result was 45. The doctor questioned this result as it did not fit the patient's clinical picture. On (b)(6) 2017, the sample was repeated with a result of 205. There was no allegation that an adverse event occurred. The bun reagent lot number is 245762; the expiration date was not provided. Quality controls were acceptable. The alarm log showed an "abnormal aspiration" alarm which indicated a sample quality issue. The customer has had no further issues since the date of the event. A specific root cause for this event could not be identified. Additional information was requested for investigation but was not provided. The most likely root cause was a sample quality/pre-analytical handling issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-01783 |
| MDR Report Key | 6809522 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-08-22 |
| Date of Report | 2017-08-22 |
| Date of Event | 2017-08-01 |
| Date Mfgr Received | 2017-08-03 |
| Date Added to Maude | 2017-08-22 |
| 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 8000 C (701) MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | CDQ |
| Date Received | 2017-08-22 |
| Model Number | C701 |
| Catalog Number | 05641489001 |
| 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 8000 C (701) MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-08-22 |
| Model Number | C701 |
| Catalog Number | 05641489001 |
| 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 | 2017-08-22 |