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 2017-06-23 for COBAS 8000 C (701) MODULE C701 05641489001 manufactured by Roche Diagnostics.
[78259109]
This event occurred in (b)(6). Unique identifier (udi)#: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[78259110]
The customer stated that they received an erroneous result for one patient sample tested for ureal urea/bun (bun) on a cobas 8000 c (701) module - c701. It was asked, but it is not known if the erroneous result was reported outside of the laboratory. There was no problem with other assays. The sample initially resulted as 1. 18 mmol/l and repeated as 10. 95 mmol/l. No adverse events were alleged to have occurred with the patient. The bun reagent lot number was 225309, with an expiration date of 12/31/2017. Upon review of quality control data, controls were ok on the date of the event, but did not appear to be stable between (b)(6) 2017. Upon review of the alarm trace, reaction cell and aspiration alarms were observed on the date of the event.
Patient Sequence No: 1, Text Type: D, B5
[118339122]
The reaction cells of the analyzer were replaced and the customer has had no further issues since this action.
Patient Sequence No: 1, Text Type: N, H10
[132606687]
A specific root cause could not be determined based on the provided information. Additional information required for the investigation was requested but not provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-01309 |
| MDR Report Key | 6662763 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-06-23 |
| Date of Report | 2017-07-20 |
| Date of Event | 2017-06-07 |
| Date Mfgr Received | 2017-06-08 |
| Date Added to Maude | 2017-06-23 |
| 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 8000 C (701) MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | CDQ |
| Date Received | 2017-06-23 |
| Model Number | C701 |
| Catalog Number | 05641489001 |
| 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 8000 C (701) MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-06-23 |
| Model Number | C701 |
| Catalog Number | 05641489001 |
| 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 | 2017-06-23 |