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

Model Number FHC-A202

Device Problem False Negative Result (1225)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/31/2020

Event Type  malfunction  

Event Description

On 08/31/2020: the customer reported that after reading a cardinal health rapid hcg combo test at 3 minutes, the result was negative with only the control line visible.When read again after 10 minutes a faint line was observed.The same day confirmatory serum quant performed in the er was positive at 30,000 iu/ml.The patient had 1000 ml of normal saline before providing the freshly voided, "very diluted" sample.There was no negative patient outcome, no additional medical procedures performed.

Manufacturer Narrative

D4: udi: (b)(4).Exp date 12/31/2021.D8: no.D9: no.H6: health effect: clinical code 4582.Health effect: impact code 2199.Component code 3121.Investigation conclusion: the reported lot number, hcg91022085, is not a valid lot number.Attempts to verify the proper lot number were unsuccessful.Investigation was pursued with similar lot number hcg9122085.Retained devices from lot number hcg9122085 were tested with qc cut-off standard (20miu/ml) and high hcg clinical urine samples (205.3iu/ml, 213.8iu/ml, and 231.9iu/ml).The results were read at 3 minutes and all devices yielded the expected positive results.No false negative results were observed during in-house testing.The case details were reviewed along with the complaint history for the reported issue and no indications of a systemic issue were identified.Manufacturing batch record review did not uncover any abnormalities and found that the lot met quality control specifications.Review of the risk management report for this product found that the reported issue is within the risk profile for this device; no new hazard has been identified.Review of the case details identified several deviations in technique such as interpreting the test past the 3-4 minute read time with an unclear background.Additionally, the sample was described to be very diluted as the patient was given 1000 ml of saline prior to urinalysis.Per the package insert, very dilute urine specimens, as indicated by a low specific gravity, may not contain representative levels of hcg.If pregnancy is still suspected, a first morning urine specimen should be collected 48 hours later and tested.This cannot ruled out as a potential cause for the reported issue.Complaints are tracked and trended on a monthly basis.

• Brand Name: CARDINAL HEALTH RAPID TEST HCG COMBO 30T
• Type of Device: HCG PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO; 9975 summers ridge rd; san diego CA 92121
• MDR Report Key: 10501443
• MDR Text Key: 217167436
• Report Number: 2027969-2020-00051
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• PMA/PMN Number: K062361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: FHC-A202
• Device Lot Number: HCG91022085
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/31/2020
• Initial Date FDA Received: 09/08/2020
• Supplement Dates Manufacturer Received: 09/28/2020
• Supplement Dates FDA Received: 09/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1