MAUDE Adverse Event Report: CARDINAL HEALTH RAPID TEST HCG COMBO 30T; HCG PREGNANCY TEST

Model Number FHC-A202

Device Problem False Negative Result (1225)

Patient Problem Abdominal Pain (1685)

Event Date 12/13/2016

Event Type  Injury  

Manufacturer Narrative

Investigation pending.

Event Description

On (b)(6) 2016: positive hcg via unspecified method but patient had possible miscarriage.There is no evidence or allegation that the cardinal health rapid test hcg combo test caused or contributed to the possible miscarriage.On (b)(6) 2016: home pregnancy test= positive x1, false negative cardinal health rapid test hcg combo x1 on (b)(6) 2016: patient went to emergency room with abdominal pain and vaginal bleeding; emergency room hcg result= 13 miu/ml on (b)(6) 2016: patient went to emergency room with abdominal pain and vaginal bleeding; emergency room hcg result= 16 miu/ml no additional information was provided.

Manufacturer Narrative

Investigation conclusion: the customer's observation was not replicated in-house with retention products.Retention products were tested with 20miu/ml hcg urine control.Retention products showed hcg positive results at read time and met qc specifications.No false negative results were obtained.Manufacturing batch record review did not uncover any abnormalities.Based on the information available, there is no indication of a product deficiency and no corrective action is required.

Event Description

On (b)(6) 2016: positive hcg via unspecified method but patient had possible miscarriage.There is no evidence or allegation that the cardinal health rapid test hcg combo test caused or contributed to the possible miscarriage.On (b)(6) 2016: home pregnancy test= positive x1, false negative cardinal health rapid test hcg combo x1.On (b)(6) 2016: patient went to emergency room with abdominal pain and vaginal bleeding; emergency room hcg result= 13 miu/ml.On (b)(6) 2016: patient went to emergency room with abdominal pain and vaginal bleeding; emergency room hcg result= 16 miu/ml.The customer provided a patient diagnosis of complete spontaneous abortion.Customer was unable to further clarify if this was referring to possible miscarriage in (b)(6).Although requested, customer was unable to provide an update on the status of the pregnancy.No additional information was provided.

• Brand Name: CARDINAL HEALTH RAPID TEST HCG COMBO 30T
• Type of Device: HCG PREGNANCY TEST
• Manufacturer Contact: ya-ling king ; 9975 summers ridge road; san diego, CA 92121 ; 8588052084
• MDR Report Key: 6251073
• MDR Text Key: 64794313
• Report Number: 2027969-2017-00013
• 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: consumer,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FHC-A202
• Device Lot Number: HCG6040036
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2017
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 31 YR