MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-04-26 for ACCUTREND CHOLESTEROL 05213312160 manufactured by Roche Diagnostics.
[43609665]
.
Patient Sequence No: 1, Text Type: N, H10
[43609666]
The reporter stated that a cholesterol value of 238 mg/dl was obtained on the accutrend meter (serial number (b)(4)). One week later a laboratory draw was done and the result was 146 mg/dl. The laboratory draw was done as a follow-up to the meter result. There were no treatments given or delayed. The controls on the meter were run and they were in range before and after the stated result. It was stated that the patient had normal physical activity and food and drink. The patient is doing well. There was no adverse event. The suspect product was requested to be returned and the replacement product was sent.
Patient Sequence No: 1, Text Type: D, B5
[46696482]
A specific root cause for the event could not be determined. The product was not returned for investigation. Retention samples were tested with control solution. The results were within the range and there were no abnormalities. The customer product was not returned.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-00489 |
| MDR Report Key | 5607406 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-04-26 |
| Date of Report | 2016-06-06 |
| Date of Event | 2016-03-08 |
| Date Mfgr Received | 2016-03-31 |
| Date Added to Maude | 2016-04-26 |
| 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 | ACCUTREND CHOLESTEROL |
| Generic Name | CHOLESTEROL (TOTAL) TEST SYSTEM |
| Product Code | CHH |
| Date Received | 2016-04-26 |
| Model Number | NA |
| Catalog Number | 05213312160 |
| Lot Number | 20402521 |
| ID Number | NA |
| Device Expiration Date | 2016-10-31 |
| 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 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-04-26 |