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 2017-10-17 for COBAS 8000 C 702 MODULE C702 06473245001 manufactured by Roche Diagnostics.
[90644239]
Unique identifier (udi)# (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[90644240]
The customer complained of an issue with their cobas 8000 c 702 module. The customer first noticed a problem with the analyzer when their controls for alb2 albumin gen. 2 were out of range. The customer did not provide any specific albumin patient results and there was no indication of any patients being affected by the albumin results obtained. The field engineering specialist found damaged tubing on the cell rinse mechanism that was leading to leaking into the reaction cells. He fixed the damaged tubing and observed the analyzer was functioning correctly. The customer performed calibration and qc which all was in range. The customer then repeated patient samples and provided the hdlc3 hdl-cholesterol plus 3rd generation (hdlc3) results for two patients of which both are a reportable malfunction. For patient #1 the initial hdlc3 result was 143 mg/dl with a repeat result of 39 mg/dl. For patient #2 the initial hdlc3 result was 151 mg/dl with a repeat result of 45 mg/dl. The initial results for hdlc3 were reported outside of the laboratory. The repeat results were deemed to be correct and corrected reports had to be issued. The customer was unsure if there were any adverse events and said he would not be able to find out for sure. There was no patient information provided by the customer. The hdl-cholesterol reagent lot was 200769 with an expiration date that was requested but not provided. The samples were aliquoted by a modular pre-analytics system.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-02343 |
| MDR Report Key | 6954108 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-10-17 |
| Date of Report | 2017-11-01 |
| Date of Event | 2017-10-03 |
| Date Mfgr Received | 2017-10-03 |
| Date Added to Maude | 2017-10-17 |
| 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 | 0 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| 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 702 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | CJW |
| Date Received | 2017-10-17 |
| Model Number | C702 |
| Catalog Number | 06473245001 |
| 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-17 |