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 2018-05-25 for ACCUTREND CHOLESTEROL 11418262171 manufactured by Roche Diagnostics.
[109753373]
(b)(4). (b)(6). Device requested for investigation but was unavailable.
Patient Sequence No: 1, Text Type: N, H10
[109753374]
The customer received questionable cholesterol results from accutrend plus meter serial (b)(4). The date of event is an approximation. The customer provided cholesterol results of "lo" (< 150 mg/dl), 250 mg/dl, and 165 mg/dl. Different fingers were used for each measurement. It was not known when the "lo" result was obtained, but it was provided that the 250 mg/dl and the 165 mg/dl results were obtained 15 minutes apart. It is unknown if the erroneous results were released to the patient or the patient's doctor. There was no allegation of an adverse event. It was provided that the customer did not apply enough blood to cover the entire test area. The customer's current condition was provided as well. The customer's meter and strips were requested for investigation. The customer's strips were no longer available. The investigation is currently ongoing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-01594 |
| MDR Report Key | 7544153 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-05-25 |
| Date of Report | 2018-05-31 |
| Date of Event | 2018-05-07 |
| Date Mfgr Received | 2018-05-07 |
| Date Added to Maude | 2018-05-25 |
| 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 FAMILY MEMBER OR FRIEND |
| 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 | 2018-05-25 |
| Model Number | NA |
| Catalog Number | 11418262171 |
| Lot Number | ASKU |
| ID Number | NA |
| 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 | 2018-05-25 |