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 2011-07-27 for CHOLESTEROL 11491458216 manufactured by Roche Diagnostics.
[2039611]
The user received questionable cholesterol results from the analytical p module analyzer (b)(4). Of the data provided, the results for one patient sample were discrepant. The initial result was 3 mg/dl and the repeat result was 229 mg/dl. No information was provided to determine if the erroneous results were reported outside the laboratory or if the patient was adversely affected.
Patient Sequence No: 1, Text Type: D, B5
[9204510]
It was unknown if the initial reporter sent report to the fda. This event occurred in (b)(6). Other assays related to this event are reported in medwatch reports with patient identifiers: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[9498382]
The investigation determined the root cause was inappropriate pre- analytical procedures by the user. The storage condition, collection procedure, centrifuge time and rpm (g force) for patient samples were evaluated. The user agreed there were inappropriate pre-analytical procedures. As the values generated as part of the issue were not medically plausible and the implausibility can be recognized, a medical risk related to this event was not likely.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2011-04013 |
| MDR Report Key | 2179684 |
| Report Source | 01,05,06 |
| Date Received | 2011-07-27 |
| Date of Report | 2011-11-30 |
| Date of Event | 2011-06-30 |
| Date Mfgr Received | 2011-07-03 |
| 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) 68300 |
| Manufacturer Postal Code | 68300 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHOLESTEROL |
| Generic Name | CHOLESTEROL |
| Product Code | CHH |
| Date Received | 2011-07-27 |
| Model Number | NA |
| Catalog Number | 11491458216 |
| Lot Number | ASKU |
| 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 | 9118 HAGUE ROAD NA INDIANAPOLIS IN 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-07-27 |