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 2017-10-11 for COBAS 6000 C (501) MODULE 04745914001 manufactured by Roche Diagnostics.
[90309147]
(b)(4). The event occurred in: (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[90309148]
The customer complained of a low chol2 cholesterol gen. 2 test result for one patient sample that was run on a cobas 6000 c (501) module (c501). On (b)(6) 2017 an initial cholesterol result of 138. 6 mg/dl was reported to the patient. The patient did not agree with this result and requested a repeat test. Repeat testing of the same sample tube was performed on (b)(6) 2017 and a cholesterol result of 227. 8 mg/dl was obtained. The repeat cholesterol result was deemed to be correct. There was no allegation of an adverse event. The customer decided to repeat other patient samples retrospectively but no other discrepancies were discovered. No specific results were provided. The cholesterol reagent lot number was 25068501 with an expiration of 31-jan-2018. The customer stated that the instrument's maintenance is up to date and all probes appear okay. They had no problems with any other tests.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-02252 |
| MDR Report Key | 6939590 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-10-11 |
| Date of Report | 2017-11-01 |
| Date of Event | 2017-09-21 |
| Date Mfgr Received | 2017-09-22 |
| Date Added to Maude | 2017-10-11 |
| 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 C (501) MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | CHH |
| Date Received | 2017-10-11 |
| Model Number | NA |
| Catalog Number | 04745914001 |
| 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 | 2017-10-11 |