MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-03-01 for LIFESCAN ONE TOUCH 11 manufactured by Lifescan.
[15109]
During normal testing of blood glucose level of the patient, a reading of 65 was observed on the meter. The patient's appearance suggested there was a problem. So, blood samples were taken. The results showed a glucose level of 26, indicating the patient was in hypoglycemic shock.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 20603 |
| MDR Report Key | 20603 |
| Date Received | 1995-03-01 |
| Date of Report | 1995-01-30 |
| Date of Event | 1995-01-18 |
| Report Date | 1995-01-31 |
| Date Reported to Mfgr | 1995-01-21 |
| Date Added to Maude | 1995-03-24 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIFESCAN |
| Generic Name | GLUCOSE METER |
| Product Code | LHE |
| Date Received | 1995-03-01 |
| Returned To Mfg | 1995-01-21 |
| Model Number | ONE TOUCH 11 |
| Device Availability | R |
| Device Age | 24 MO |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 20486 |
| Manufacturer | LIFESCAN |
| Manufacturer Address | 1000 GIBRALTER DR. MILITAS CA 95035 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1995-03-01 |