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 2017-10-09 for HDLC3 HDL-CHOLESTEROL PLUS 3RD GENERATION manufactured by Roche Diagnostics.
[89951907]
(b)(4). The event occurred in: (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[89951908]
The customer complained of high hdlc3 hdl-cholesterol plus 3rd generation (hdlc3) results for 3 patient samples. When comparing the results from two cobas 6000 c (501) modules (c501) against the results from an abbott system, the results did not correlate. The results for two of the patient samples were a reportable malfunction. For sample 1 the initial hdlc3 result from c501 (analyzer a) was 149 mg/dl with a repeat diluted result of 159 mg/dl using hdlc3 reagent lot number 163062. The sample was run on another c501 (analyzer b) with an initial result of 147 mg/dl and a repeat diluted result of 166 mg/dl using hdlc3 reagent lot number 201693 with expiration date of 30-sep-2018. The abbott result for the same sample was 45 mg/dl and was believed to be clinically correlating. For sample 2 the initial hdlc3 result from analyzer a was 156 mg/dl with a repeat diluted result of 177 mg/dl using hdlc3 reagent lot number 163062. The sample was run on analyzer b with an initial result of 141 mg/dl and a repeat diluted result of 149 mg/dl using hdlc3 reagent lot number 201693. The abbott results for the same sample were 28 mg/dl and 29 mg/dl and were believed to be clinically correlating. The results from analyzer a and analyzer b were not reported outside of the laboratory. There was no allegation of an adverse event. The qc results on the both analyzer a and analyzer b were in range on the day of event. Analyzer a serial number was 16v9-08 and analyzer b serial number was 16z0-06. The investigation is currently ongoing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-02223 |
| MDR Report Key | 6928677 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-10-09 |
| Date of Report | 2018-01-02 |
| Date of Event | 2017-09-18 |
| Date Mfgr Received | 2017-09-19 |
| Date Added to Maude | 2017-10-09 |
| 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 | 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 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 116 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) 68305 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 68305 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HDLC3 HDL-CHOLESTEROL PLUS 3RD GENERATION |
| Generic Name | CHOLESTEROL VIA ESTERASE-OXIDASE, HDL |
| Product Code | LBS |
| Date Received | 2017-10-09 |
| Model Number | NA |
| Catalog Number | ASKU |
| Lot Number | 163062 |
| ID Number | NA |
| Device Expiration Date | 2018-04-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-09 |