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 HDL-C PLUS 3RD GENERATION 04713257190 manufactured by Roche Diagnostics.
[17103072]
The user received questionable hdl results from the analytical p module analyzer serial number (b)(4). Of the data provided, the results for two patient samples were discrepant. All results are in mg/dl. Patient sample 1 initial result was 1 and the repeat result was 61. Patient sample 2 initial result was 1 and the repeat result was 40. No information was provided to determine if the erroneous results were reported outside the laboratory or if the patients were adversely affected.
Patient Sequence No: 1, Text Type: D, B5
[17314779]
This event occurred in (b)(6). Other assays related to this event are reported in medwatch reports with patient identifiers: (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[18084305]
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 | 1823260-2011-04012 |
| MDR Report Key | 2180032 |
| 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 | HDL-C PLUS 3RD GENERATION |
| Generic Name | LDL & VLDL PRECIPITATION, CHOLESTEROL VIA ESTERASE-OXIDASE, HDL |
| Product Code | LBS |
| Date Received | 2011-07-27 |
| Model Number | NA |
| Catalog Number | 04713257190 |
| 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 |