MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2001-06-21 for LABSTIX * 2810A manufactured by Bayer Diagnostics.
[18949467]
A physician from uk complained that the urine glucose readings were reading false negative using bayer visual reagent strips product, labstix. Physician claims that the pt is now in serious risk of falling into a diabetic coma. The urine and blood tests have been sent to the laboratory and confirmed that the patient's glucose levels in blood sample are abnormally high. In house investigation of affected product did not confirm the alleged complaint. The product claims clearly indicate that the product is intended as a screen test to identify potential diabetics who's blood glucose levels are high enough to cause to spill glucose over that individual's threshold into the urine. The product is not intended to monitor or regulate a diabetic's blood glucose level. It seems to be the approach taken by the physician who reported this complaint.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1810909-2001-00036 |
| MDR Report Key | 339721 |
| Report Source | 05 |
| Date Received | 2001-06-21 |
| Date of Report | 2001-06-21 |
| Date of Event | 2001-04-16 |
| Date Mfgr Received | 2001-04-16 |
| Device Manufacturer Date | 2000-05-01 |
| Date Added to Maude | 2001-07-02 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | SY ATAULLAH MANAGER |
| Manufacturer Street | 1884 MILES AVENUE |
| Manufacturer City | ELKHART IN 46515 |
| Manufacturer Country | US |
| Manufacturer Postal | 46515 |
| Manufacturer Phone | 2192626865 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LABSTIX |
| Generic Name | IVD - URINALYSIS-MULTIPLE VISUAL/GLUCOSE PARAMETERS |
| Product Code | JIO |
| Date Received | 2001-06-21 |
| Model Number | * |
| Catalog Number | 2810A |
| Lot Number | 0E03C |
| ID Number | * |
| Device Expiration Date | 2001-11-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 329045 |
| Manufacturer | BAYER DIAGNOSTICS |
| Manufacturer Address | WESTERN AVENUE BRIDGEND INDUSTRIAL ESTATE BRIDGEND, SOUTH WALES UK CF31 3TY |
| Baseline Brand Name | LABSTIX |
| Baseline Generic Name | MULTIPLE VISUAL REAGENT STRIPS PRODUCT/LUCOSE PARAMETERS |
| Baseline Model No | 2810A |
| Baseline Device Family | NA |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | 18 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K831600 |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2001-06-21 |