Model Number FHC-A102-OBC554 |
Device Problems
False Negative Result (1225); Incorrect, Inadequate or Imprecise Result or Readings (1535)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 12/03/2014 |
Event Type
malfunction
|
Event Description
|
Caller alleging receiving false negative urine hcg results using hcg cassette for two patients.Hcg product received a negative result, patient went to emergency room and was evaluated as positive.Patient 2 (b)(6) - email from distributor alleges patient went into doctor's office with abdominal pain.The pregnancy test gave a false negative result and patient was sent to the emergency room where she was confirmed positive.Patient was 9 weeks pregnant.All of this took place on the same day and the patient and baby are in good condition now.No additional information was provided.Mdr #2027969-2014-01099 submitted to address the complaint for patient 1.
|
|
Manufacturer Narrative
|
Investigation conclusion: customer's observation was not replicated in-house with retention devices.Retention devices were tested with 20 miu/ml cutoff hcg urine control and 3 high level hcg urine controls, all results were positive at read time.No false negative were obtained.Manufacturing batch record review did not uncover any abnormalities.Root cause could not be determined without patient specimen in-house analysis.Based on the information available, there is no indication of a product deficiency.No corrective action is required at this time.
|
|
Search Alerts/Recalls
|