[20436225]
On 1/28/93, patient was administered a test screening for mono test. The purchase datawas 8/31/92, per attached invoice. The test was conducted within four months of the purchase dte. Patient showed a positive test result and was prescribed medication by doctor for treatment of mono. Patient's condition worsened and he subsequently sought medical treatment from another facility where he incurred further medical bills for $621. 50. Test result taken at this facility revealed patient did not have mono, but diagnosed as having acute pharyngitis. Patient returned to original facility for an explanation and was retested by the same lpn using the same consise mono test kit and showed a negative test result. The concise test kit had an expiration date on the outside box as being 12/93, however the vials expiration dates were 2/93invalid data - regarding single use labeling of device. Patient medical status prior to event: invalid data. There was not 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: none or unknown. Results of evaluation: none or unknown. Conclusion: none or unknown. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: none or unknown. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5