MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 02,04 report with the FDA on 2004-12-10 for GLUCOMETER DEX 3952E * manufactured by Bayer Healthcare Llc.
[21256015]
Customer stated that she tested with this meter and compared it to another meter and received the following results: @ 10:26pm - this meter = 103mg/dl, other meter = 28 mg/dl, @ 10:36pm - this meter = 46mg/dl, other meter = 34mg/dl, @ 11:07pm - this meter=106mg/dl, other meter = 71mg/dl. A review of the system was conducted over the phone. The review indicated that the meter performed according to specifications. The customer was asked to return the meter for the further evaluation and a replacement was provided. The customer was invited to call with future questions/concerns.
Patient Sequence No: 1, Text Type: D, B5
[21434097]
Upon receipts, performance testing was conducted. Testing determined that the meter performed according to specifications - the complaint could not be duplicated. This complains is considered closed for purposes of mdr.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1810909-2004-00360 |
| MDR Report Key | 794293 |
| Report Source | 02,04 |
| Date Received | 2004-12-10 |
| Date of Report | 2004-12-08 |
| Date of Event | 2004-06-03 |
| Date Mfgr Received | 2004-06-03 |
| Device Manufacturer Date | 2001-10-01 |
| Date Added to Maude | 2006-12-15 |
| 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 | 0 |
| Manufacturer Contact | FRED MCCLURE, ASSOCIATE |
| Manufacturer Street | 1884 MILES AVENUE |
| Manufacturer City | ELKHART IN 46514 |
| Manufacturer Country | US |
| Manufacturer Postal | 46514 |
| Manufacturer Phone | 5702626929 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GLUCOMETER DEX |
| Generic Name | BLOOD GLUCOSE METER |
| Product Code | DEX |
| Date Received | 2004-12-10 |
| Returned To Mfg | 2004-06-24 |
| Model Number | 3952E |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 781913 |
| Manufacturer | BAYER HEALTHCARE LLC |
| Manufacturer Address | * MISHAWAKA IN 46544 US |
| Baseline Brand Name | GLUCOMETER DEX |
| Baseline Generic Name | BLOOD GLUCOSE METER |
| Baseline Model No | 3952E |
| Baseline Catalog No | * |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-12-10 |