MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2001-05-14 for SURESTEP manufactured by Lifescan, Inc..
[15031400]
Patient reported their back to back test readings obtained on their ss meter using different finger sticks were 450 and 270 mg/dl (50% diference). No symptoms were reported. On follow-up, patient confirmed the above information. Patient is new ss meter user and is not doing test procedure correctly (patient is applying blood on confirmation dot). Lfs representative reviewed qc and testing procedures with patient and discussed back to back testing versus meter/lab comparisons. There was no allegation of harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939301-2001-00433 |
| MDR Report Key | 333686 |
| Report Source | 04 |
| Date Received | 2001-05-14 |
| Date of Report | 2001-04-15 |
| Date Mfgr Received | 2001-04-15 |
| Date Added to Maude | 2001-05-22 |
| 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 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JOHN HUGHES |
| Manufacturer Street | 1000 GIBRALTAR DRIVE |
| Manufacturer City | MILPITAS CA 95035 |
| Manufacturer Country | US |
| Manufacturer Postal | 95035 |
| Manufacturer Phone | 4089425903 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SURESTEP |
| Generic Name | BLOOD GLUCOSE MONITORING KIT/SYSTEM |
| Product Code | GFC |
| Date Received | 2001-05-14 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 323051 |
| Manufacturer | LIFESCAN, INC. |
| Manufacturer Address | 1000 GIBRALTAR DR. MILPITAS CA 95035 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-05-14 |