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

Model Number FHC-102

Device Problem False Negative Result (1225)

Patient Problem Ectopic Pregnancy (1819)

Event Type  Injury  

Manufacturer Narrative

Customer unresponsive.Results pending investigation.

Event Description

Unspecified date: false negative result on the medline hcg urine cassette test kit.Customer states the patient was in the hospital with an ectopic pregnancy due to the false negative result.Failure to identify an ectopic pregnancy due to a false negative hcg result will be considered life-threatening.Four attempts were performed in a fourteen day period to obtain additional information regarding the event, however, the customer is unresponsive.No further information was able to be obtained.

Manufacturer Narrative

Investigation conclusion: an investigation was performed on retention product from the reported lot number.Retention devices were tested with cut-off standards (25 miu/ml) and high positive standards (212iu/ml, 212.9iu/ml, and 215.6iu/ml.Results were read at 3 minutes and all devices yielded expected positive results results.No false negatives 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.A root cause could not be determined from the available information as the reported issue was not replicated during testing of retention product.Complaints are tracked and trended on a monthly basis.Please note, a first morning urine specimen is preferred since it generally contains the highest concentration of hcg; however, urine specimens collected at any time of the day may be used.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.

• Brand Name: MEDLINE HCG URINE CASSETTE
• Type of Device: PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge road; san diego CA 92121
• MDR Report Key: 10943269
• MDR Text Key: 219498962
• Report Number: 2027969-2020-00081
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• PMA/PMN Number: K993317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 01/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: FHC-102
• Device Lot Number: HCG9112049
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening