MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. CONSULT HCG URIN/SRM COMBO 5002 25; PREGNANCY TEST

Model Number FHC-A202

Device Problem False Negative Result (1225)

Patient Problem Miscarriage (1962)

Event Date 01/28/2020

Event Type  malfunction  

Manufacturer Narrative

Devices not returned.Customer to monitor - troubleshooting provided.Results pending investigation.

Event Description

(b)(6) 2020: patient contacted facility after obtaining a positive result on a home pregnancy test (unspecified brand/specificity) and passing some tissue.Date home pregnancy test was performed is unknown.Patient was advised to come into the facility.Patient urine sample was tested on the consult hcg combo cassette and a negative result was obtained.The urine specimen was not quantified.The facility performed a confirmatory blood test which provided a positive result of 268 miu/ml.All tests were performed on the same day but the exact times were not provided.The facility then performed an ultrasound on the same day, which revealed the patient has experienced a miscarriage.Customer states miscarriage was spontaneous in nature.No treatment was provided or withheld based on the false negative result obtained on the consult hcg combo cassette.Customer states they have three different lots at their facility, but was unable to identify which lot was used for the test.The following lots were in use at the facility: hcg9082045, hcg9082044, hcg8100020.Situations in which a patient experiences a miscarriage following a false negative hcg result will be considered limited such that the miscarriage is natural and not caused by the administration of any medications or interventions.Based on fda's guidance for "instructions for completing form fda 3500": for cases describing fetal death, miscarriage or abortion, the mother is the patient in the report (section a).Do not check "death" as an outcome attributed to the adverse event if a fetus is aborted because of a congenital anomaly (birth defect), or is miscarried.Based on the above guidance and instructions, this event is not mdr reportable as a death event.Only one mdr is being filed as there was only one event and the lot in use is unknown.

Manufacturer Narrative

Additional information: update to section h6: method code 11 added.Results code 213 added.Conclusions code 67 added.Udi's for the reported lot numbers: (b)(4).Investigation conclusion: retained devices from the reported lot numbers (hcg8100020, hcg9082045, hcg9082044) were tested with cut-off standards (25 miu/ml) and middle positive standards (100 miu/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 relevant non-conformances 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.Per the package, 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: CONSULT HCG URIN/SRM COMBO 5002 25
• Type of Device: PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge rd.; san diego, ca
• MDR Report Key: 9706804
• MDR Text Key: 188845289
• Report Number: 2027969-2020-00003
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 03/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FHC-A202
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DEPO-PROVERA
• Patient Age: 33 YR
• Patient Weight: 61