[2535]
Every morning i faithfully checked my blood with the supreme and every morning my wife and i were pleased to see that my blood sugar registered low. On 8/6 we left salt lake city and headed home. That morning when i checked my blood around 7:30 a. M. , the glucometer measured my blood sugar at 93. I still did not feel very well and after arriving home i went straight to the hospital. In the emergency room, the hospital technicians discovered my blood sugar to high to even measure. Later with another device, it registered in excess of 900. I was hospitalized and treated for ketosis. After being released i had a regular doctor's appointment in which iwas checked with the supreme device which registered at 92 while the clinic's instrument registered at 358. Had i relied on the supreme any longer, the outcome would have been fetaldevice not labeled for single use. Patient medical status prior to event: invalid data. Invalid data - regarding multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Invalid data - whether device used as labeled/intended. Invalid data - regarding evaluation by user after event. Method of evaluation: invalid data. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: yes. Corrective actions: none or unknown. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5