MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. CONSULT DIAGNOSTICS HCG CASSETTE; HCG PREGNANCY TEST

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 1 id (b)(6) - email from distributor stated the patient was already in the stage of miscarriage when she went in to the doctor's office, complaining of abdominal pain.The pregnancy test gave a false negative result and she was sent to the emergency room where it was confirmed positive.She was 4 weeks pregnant.Doctor's office confirmed that patient went to the hospital the same day as she was seen in the doctor's office with abdominal pain." although multiple attempts were made to obtain additional and follow-up information, no additional information was provided.Mdr #2027969-2014-01100 submitted to address the complaint for second patient.

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 negatives 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.

• Brand Name: CONSULT DIAGNOSTICS HCG CASSETTE
• Type of Device: HCG PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; san diego CA
• Manufacturer Contact: ya-ling king ; 9975 summers ridge rd; san diego, CA 92121 ; 8588052084
• MDR Report Key: 4384792
• MDR Text Key: 5125275
• Report Number: 2027969-2014-01099
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FHC-A102-OBC554
• Device Lot Number: HCG4010136
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1