MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2019-05-03 for ACCUTREND CHOLESTEROL 11418262171 manufactured by Roche Diagnostics.
[143958267]
The event occurred in (b)(6). Occupation: occupation ni equals lay user / patient.
Patient Sequence No: 1, Text Type: N, H10
[143958268]
The initial reporter complained of questionable results from an accutrend plus meter serial number (b)(4). At 6:19 am the result from the meter was 5. 30 mmol/l. At 6:26 am the result from the meter was 6. 93 mmol/l. At 6:36 am the result from the meter was 4. 29 mmol/l. At 6:41 am the result from the meter was 6. 46 mmol/l. The erroneous results were reported outside of the laboratory. There was no allegation of an adverse event. The customer stated that they perform the testing first thing in the morning after fasting. The customer's meter and test strip have been requested for return.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2019-01667 |
| MDR Report Key | 8577179 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2019-05-03 |
| Date of Report | 2019-08-15 |
| Date of Event | 2019-03-23 |
| Date Mfgr Received | 2019-04-11 |
| Date Added to Maude | 2019-05-03 |
| 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 | 2019-05-03 |
| Model Number | NA |
| Catalog Number | 11418262171 |
| Lot Number | 34902402 |
| Device Expiration Date | 2019-10-31 |
| 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 | 2019-05-03 |