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 2017-10-20 for COBAS 6000 C501 MODULE 05860636001 manufactured by Roche Diagnostics.
[90768595]
(b)(4). (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[90768596]
The customer complained of questionable trigl triglycerides (trigl) results for two patient samples. For patient 1 the initial trigl result was 580 mg/dl. The repeat result was 87 mg/dl. For patient 2 the initial trigl result was 600 mg/dl. The repeat result was 98 mg/dl. The initial results were reported outside of the laboratory. The repeat testing was performed on another analyzer. The repeat results were deemed to be correct. There was no allegation of an adverse event. The trigl reagent lot was 23611201 with an expiration date of 30-apr-2018. A specific root cause could not be identified. Further investigation excluded a general reagent problem due to calibration and qc results being acceptable. It was noted that the customer changes the calibration factors after performing quality control testing. The customer was informed that this not recommended. The alarm trace for the analyzer showed frequent probe alarms. The customer cleaned the probes and is having no further issues.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-02386 |
| MDR Report Key | 6965215 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-10-20 |
| Date of Report | 2017-10-20 |
| Date of Event | 2017-10-05 |
| Date Mfgr Received | 2017-10-06 |
| Date Added to Maude | 2017-10-20 |
| 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 |
| 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 | JGY |
| Date Received | 2017-10-20 |
| 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-20 |