MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2014-02-21 for TRUETRACK A4H01-81 manufactured by Home Diagnostics, Inc..
[52987107]
(b)(4). Product not yet returned.
Patient Sequence No: 1, Text Type: N, H10
[52987108]
Consumer complaint of high blood results. Customer normally is 115-130 mg/dl two hours after breakfast. Based on parkes error grid analysis, the bias between the highest result given (344) and the normal result (115) is located in zone c. No adverse event reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1052693-2014-00117 |
| MDR Report Key | 3802525 |
| Report Source | CONSUMER |
| Date Received | 2014-02-21 |
| Date of Report | 2014-04-09 |
| Date of Event | 2014-03-12 |
| Date Mfgr Received | 2014-03-12 |
| Date Added to Maude | 2014-05-09 |
| 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 | KAREN DEVINCENT |
| Manufacturer Street | 2400 N.W. 55TH CT. |
| Manufacturer City | FORT LAUDERDALE FL 33309 |
| Manufacturer Country | US |
| Manufacturer Postal | 33309 |
| Manufacturer Phone | 9546779201 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | TRUETRACK |
| Generic Name | BLOOD GLUCOSE SYSTEM |
| Product Code | NUI |
| Date Received | 2014-02-21 |
| Model Number | TRUETRACK |
| Catalog Number | A4H01-81 |
| Lot Number | RP4145 |
| 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 | HOME DIAGNOSTICS, INC. |
| Manufacturer Address | 2400 N.W. 55TH CT. FORT LAUDERDALE FL 33309 US 33309 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-02-21 |