MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 1996-12-31 for ONE TOUCH BASIC 010-337-01F manufactured by Lifescan, Inc..
[7827451]
H6 result: no non-conformances. Co is unable to complete their investigation of the mdr incident listed above due to the fact that the meter was not returned to lifescan. Therefore, co has not been able to evaluate the meter to determine whether or not a device malfunction may have contributed to this event. Batch record review indicates no non-conformances in the manufacturing process. At this point, co considers this matter closed.
Patient Sequence No: 1, Text Type: N, H10
[21246105]
On 11/18 and 1/19, the pt obtained readings on her meter "in the 20's. " based upon the meter readings, she did not take her insulin. Because of her symptoms of being tired, weak, no energy, blurred vision, frequent urination and a dry mouth, she proceeded to the hosp on 11/19. Meter readings prior to going to hosp continued to be "in the 20's. " upon arrival, she was admitted for hyperglycemia and treated with insulin and an iv for dehydration. She was released on 11/23. The device was in calibration on 12/2, reading 85 versus a range of 70-96.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939301-1996-00044 |
| MDR Report Key | 60201 |
| Report Source | 04 |
| Date Received | 1996-12-31 |
| Date of Report | 1996-12-31 |
| Date of Event | 1996-11-19 |
| Date Mfgr Received | 1996-12-02 |
| Device Manufacturer Date | 1994-03-01 |
| Date Added to Maude | 1997-01-07 |
| 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 | 3 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ONE TOUCH BASIC |
| Generic Name | BLOOD GLUCOSE MONITORING METER |
| Product Code | FRF |
| Date Received | 1996-12-31 |
| Model Number | NA |
| Catalog Number | 010-337-01F |
| 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 | 60610 |
| Manufacturer | LIFESCAN, INC. |
| Manufacturer Address | 1000 GIBRALTAR DR MILPITAS CA 95035 US |
| Baseline Brand Name | ONE TOUCH BASIC |
| Baseline Generic Name | BLOOD GLUCOSE METER |
| Baseline Model No | NA |
| Baseline Catalog No | 010-337-01F |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 1996-12-31 |