MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2016-11-30 for ACCUTREND CHOLESTEROL 11418262171 manufactured by Roche Diagnostics.
[61098653]
(b)(4). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[61098654]
The customer received a questionable cholesterol result from accutrend plus meter serial number rr0040140 when compared to the result from an accuchek performa meter. The result from the accuchek performa was 5. 5 mmol/l. The result from the accutrend plus was 2. 1 mmol/l. The customer thought the accuchek performa result was closer to her usual result. The customer has not been tested in a laboratory. The customer was not adversely affected. The suspect meter and strips were requested to be returned for investigation.
Patient Sequence No: 1, Text Type: D, B5
[63734890]
Retention material from lot 204048-00 was tested with control material on a reference meter. The retention testing results showed no abnormalities and all results were within the tolerance ranges. Further investigation was possible as no customer material was received for investigation. A handling issue could not be excluded as a possible cause.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-01863 |
| MDR Report Key | 6134478 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2016-11-30 |
| Date of Report | 2016-12-21 |
| Date of Event | 2016-11-16 |
| Date Mfgr Received | 2016-11-16 |
| Date Added to Maude | 2016-11-30 |
| 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 |
| Reporter Occupation | PATIENT |
| 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 | ACCUTREND CHOLESTEROL |
| Generic Name | CHOLESTEROL (TOTAL) TEST SYSTEM |
| Product Code | CHH |
| Date Received | 2016-11-30 |
| Model Number | NA |
| Catalog Number | 11418262171 |
| Lot Number | 204048-05 |
| ID Number | NA |
| Device Expiration Date | 2016-12-31 |
| Operator | LAY USER/PATIENT |
| 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 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-30 |