MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2011-06-20 for CHOLESTEROL GEN.2 03039773190 manufactured by Roche Diagnostics.
[2079336]
The customer received questionable cholesterol results for one patient when tested on a cobas integra 400+ analyzer, (b)(4). The initial result was 10. 67 mmol/l and was reported to the patient. On (b)(6) 2011, the same sample was repeated and recovered 5. 43 mmol/l. This result was reported outside the laboratory on (b)(6) 2011 as the correct result. The patient visited another clinic to check the result and blood was collected a second time. The cholesterol result from this sample was not provided. No adverse events were reported. The patient's condition is "normal".
Patient Sequence No: 1, Text Type: D, B5
[9012420]
It is unknown if the initial reporter sent a report to the fda. This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[9012996]
New information was received: the cholesterol result from the second sample tested at the clinic was provided. The result was 5 mmol/l.
Patient Sequence No: 1, Text Type: N, H10
[9208935]
The investigation concluded the most likely cause of the discrepancies was a preanalytical issue (including incorrect handling of the samples or wrong storage). The instrument and assay performed according to specifications as demonstrated by the good quality control, calibration and precision. There also were no other assay outliers. Single false high cholesterol results may result in unnecessary further tests. The only impact to this patient was an additional sample draw for testing.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2011-03345 |
| MDR Report Key | 2133683 |
| Report Source | 01,05,06 |
| Date Received | 2011-06-20 |
| Date of Report | 2011-07-27 |
| Date of Event | 2011-06-09 |
| Date Mfgr Received | 2011-06-10 |
| Date Added to Maude | 2011-06-20 |
| 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 RAE ANN FARROW |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175213194 |
| 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 | 2011-06-20 |
| Model Number | NA |
| Catalog Number | 03039773190 |
| Lot Number | 639312-01 |
| ID Number | NA |
| 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 | 2011-06-20 |