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 Radiation Exposure, Unintended (3164)

Event Date 01/01/2017

Event Type  Injury  

Manufacturer Narrative

Investigation conclusion: retention devices of the reported lot were tested with cutoff serum standard (10 miu/ml hcg) and all devices produced positive results at the read time.All devices met the qc specification and no false negative results were observed.The customer's results were not replicated on retained devices tested with the returned serum sample.Retained devices tested with the returned serum produced positive results at the read time.All results met the qc specification.In-house sample testing produced results in agreement with quantitative hcg analysis of the returned sample (mean hcg = 21.4 miu/ml).No false negative results were observed during in-house testing and the product performed as expected.A review of manufacturing batch records 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) 2017, the customer performed a cardinal health rapid test hcg combo test on patient serum sample and received negative result at read time.The test yielded a (b)(6) result "several seconds" after the appropriate read time, but the result was reported as negative.The test was performed because the patient was to undergo an abdominal cat scan for abdominal pain.The patient was reported as having renal failure and was on dialysis.The cat scan was performed following the (b)(6) cardinal health rapid test hcg combo result.A beta quant was performed on the vista 1500 using the same serum sample and yielded an hcg result of 45 miu/ml (the (b)(6) range for this instrument as provided by the customer is 0-3 miu/ml).Although the beta quant provided a (b)(6) hcg result, the customer stated it is not certain that the patient is pregnant.On (b)(6) 2017, a second beta quant was performed using the vista 1500 and yielded an hcg result of 23 miu/ml.The customer noted that the hcg titer was not increasing.An ultrasound was not performed on the patient.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: 6302033
• MDR Text Key: 66550982
• Report Number: 2027969-2017-00027
• 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
• Report Date: 01/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: HCG6070189
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/05/2017
• Initial Date FDA Received: 02/03/2017
• 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): Other
• Patient Age: 32 YR