MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2011-07-27 for CHOLESTEROL GEN.2 03039773190 manufactured by Roche Diagnostics.
[9307095]
A specific root cause could not be determined with the information provided for investigation. The calibration and quality control were within specification prior to the event. No adverse events were reported in this case.
Patient Sequence No: 1, Text Type: N, H10
[16101668]
The customer received a questionable cholesterol result on their cobas c501 (serial number (b)(4)). The customer provided data for one patient sample with discrepant results reported outside the laboratory. The sample was repeated on the same analyzer on (b)(6) 2011 after the initial result was questioned. The patient's initial cholesterol result was 9 mg/dl. The repeat result was 189 mg/dl. The customer believed the 189 mg/dl result and it was issued as a corrected report. There were no adverse affects to the patient as a result of this event. The field service representative (fsr) could not determine the cause of the event. The customer re-ran the test and received accurate results. The fsr checked the fluidics system and ran precision tests. Diagnostic checks passed with in specifications. The customer performed quality control and a precision test with no further errors.
Patient Sequence No: 1, Text Type: D, B5
[16332926]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2011-04043 |
| MDR Report Key | 2180593 |
| Report Source | 05,06,07 |
| Date Received | 2011-07-27 |
| Date of Report | 2011-10-11 |
| Date of Event | 2011-07-15 |
| Date Mfgr Received | 2011-07-19 |
| Date Added to Maude | 2011-07-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | NA JENNIFER WOLFGRAM |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175217008 |
| Manufacturer G1 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 116 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) 68305 |
| Manufacturer Postal Code | 68305 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHOLESTEROL GEN.2 |
| Generic Name | ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL |
| Product Code | CHH |
| Date Received | 2011-07-27 |
| Model Number | NA |
| Catalog Number | 03039773190 |
| Lot Number | 63506801 |
| ID Number | NA |
| Device Expiration Date | 2011-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-07-27 |