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 2017-08-30 for COBAS 6000 C501 MODULE 05860636001 manufactured by Roche Diagnostics.
[84956220]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[84956221]
The customer stated they were getting low results for multiple tests that would repeat higher. At the time of testing they were getting an abnormal probe sucking alarm, but the customer could not confirm which results were affected by this alarm. The customer provided the data for two patients, of which only one patient result is a reportable malfunction. The discrepant result was obtained for chol2 cholesterol gen. 2. The initial cholesterol result was 4 mg/dl. The repeat result was 157 mg/dl. The repeat testing was deemed to be correct. The initial result was reported outside of the laboratory but, there was no adverse event. The reagent information and expiration date for chol2 cholesterol gen 2 was requested but not provided. The field engineering specialist found a problem with the fluidics of the system. He stated that the solenoid valve near the vacuum tank had failed causing water drops to collect on top of the reaction cells. He cleaned the faulty solenoid valve and adjusted the cell rinse volumes. He also ran a precision check using a pooled serum sample for all the affected tests which all passed. The customer ran qc which passed.
Patient Sequence No: 1, Text Type: D, B5
[117871504]
Further investigation showed that the customer was also having trouble with the sample probe assembly. This was evident by the "abnormal probe sucking" and "sample probe up/down alarms" generated by the analyzer. A field engineering specialist (fes) replaced the sample probe assembly. The customer ran qc testing which was acceptable. Corrosion on the sample probe connector was excluded. In combination of the above service activities along with the repair of the faulty solenoid valve that was previously reported the issue was resolved to the fes activities. The customer stated that they have had no further issues.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-01859 |
| MDR Report Key | 6830147 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-08-30 |
| Date of Report | 2017-10-31 |
| Date of Event | 2017-08-10 |
| Date Mfgr Received | 2017-08-10 |
| Date Added to Maude | 2017-08-30 |
| 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 | 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 6000 C501 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | CHH |
| Date Received | 2017-08-30 |
| Model Number | C501 |
| Catalog Number | 05860636001 |
| 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 6000 C501 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-08-30 |
| Model Number | C501 |
| Catalog Number | 05860636001 |
| 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 | 2017-08-30 |