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 2017-02-15 for ACCUTREND CHOLESTEROL 11418262171 manufactured by Roche Diagnostics.
[67597191]
(b)(4). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[67597192]
A pharmacist received questionable cholesterol results from accutrend plus meter serial number (b)(4). The initial result for a patient was "lo. " it was retested on a different finger and again gave "lo. " the customer then tested staff members and reported that they obtained differing results. Specific data was not provided. The patient was concerned as she knew she had high cholesterol and had been tested by a doctor four months earlier. She was due for retest in (b)(6) and thought she would check her progress in between tests as dietary and lifestyle changes had been made. The patient was retested by her doctor a week after the event and the cholesterol result was 6. 8 mmol/l. She then contacted the pharmacy to complain about the low results. The patient was not adversely affected. The suspect meter and strips were received for investigation. The device was contaminated with human material. No other abnormalities were seen. The customer's strips and retention samples from cholesterol lot 164187-20 were measured with two edta blood on customer meter and reference meters. Retention control solutions (low/high) were also measured with customer strips and retention strips on customer meter and reference meters. The customer samples and retention samples did not show any abnormalities. There were no significant differences from customer meter to reference meter and all results within range. The investigated material was found to be working according to the specifications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-00338 |
| MDR Report Key | 6332798 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-02-15 |
| Date of Report | 2017-02-15 |
| Date of Event | 2016-12-17 |
| Date Mfgr Received | 2017-01-31 |
| Date Added to Maude | 2017-02-15 |
| 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 | 2017-02-15 |
| Returned To Mfg | 2017-02-08 |
| Model Number | NA |
| Catalog Number | 11418262171 |
| Lot Number | 164187-23 |
| ID Number | NA |
| Device Expiration Date | 2017-09-30 |
| Operator | PHARMACIST |
| Device Availability | R |
| 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 | 2017-02-15 |