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 Problems Radiation Exposure, Unintended (3164); Pregnancy (3193)

Event Date 10/26/2016

Event Type  Injury  

Manufacturer Narrative

Investigation conclusion: investigation pending.

Event Description

Report received of false negative cardinal health rapid test hcg combo 30t.On 12/15/2016 the hospital representative called stating a patient came in to the emergency department at the (b)(6) medical center on (b)(6) 2016.Patient was a female (b)(6); last menstrual period unknown.Patient was admitted same day ((b)(6) 2016) for detox from crystal meth.Suffering from depression, insomnia and self- harm (caller unable to specify what self-harm detailed).A urine hcg test was performed with the cardinal health rapid test hcg combo 30t and a negative result obtained.Following the negative result, the patient was submitted to multiple x-rays and was put on anti-psychotic medication (brand/dosage not known by caller).On (b)(6) 2016 patient was discharged as stable.On (b)(6) 2016 patient went to her ob/gyn who determined that patient was (b)(6) pregnant.Confirmation was performed by ob/gyn during examination.The hospital was informed that the patient and ob/gyn planned to terminate the pregnancy because of the x-rays and medications given during patient's hospitalization.On 01/06/2017 alere technical services (tss) followed up with the hospital to obtain pending information regarding patient outcome.The hospital representative did not have additional patient information and stated the patient has not had the abortion performed yet.The patient first wants the hospital to take responsibility for the outcome of a recommended abortion and to also perform the abortion, which she claims was due to the complications caused by medication given based on the test result.Tss requested medical records from the hospital representative, who indicated she was unable to provide the records; however, if a written request was sent to her, she could forward it and see if permission might be given.As of (b)(6) 2017 pregnancy has not been terminated.Patient estimated to be (b)(6) pregnant.

Manufacturer Narrative

Investigation conclusion: the customer's results were not replicated in-house with retention devices of the reported lot.Retention devices were tested with 3 high level hcg urine standards (211.5 iu/ml, 217.5 iu/ml, and 218.1 iu/ml).All of the results were hcg positive at read time and met the qc release specification.No false negative results were observed during in-house testing.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.

Manufacturer Narrative

Corrections: section (outcomes attributed to adverse event) corrected to other serious (important medical events) section (additional device information) corrected lot number to hcg6060068.

• 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: 6251584
• MDR Text Key: 64899581
• Report Number: 2027969-2017-00015
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/15/2016

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 Expiration Date: 05/31/2018
• Device Model Number: FHC-A202
• Device Lot Number: HCG6060068
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/26/2017
• 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
• Treatment: UNSPECIFIED ANTI-PSYCHOTIC MEDICATIONS
• Patient Outcome(s): Other
• Patient Age: 22 YR