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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. CONSULT HCG DIPSTICK TEST 5000 25T; PREGNANCY TEST
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ALERE SAN DIEGO, INC. CONSULT HCG DIPSTICK TEST 5000 25T; PREGNANCY TEST Back to Search Results
Model Number FHC-101
Device Problem False Negative Result (1225)
Patient Problems No Known Impact Or Consequence To Patient (2692); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 06/26/2020
Event Type  Injury  
Manufacturer Narrative
Pending results of investigation.
 
Event Description
False negative result obtained on (b)(6) 2020 using the consult diagnostics hcg urine dipstick cassette kit.When customer reported issue on (b)(6) 2020, she states patient was evaluated by her physician and she is (b)(6) pregnant currently.This information indicates the patient was 4 weeks pregnant at the time the test was conducted on (b)(6) 2020.No adverse patient outcomes reported.Although requested, no further information was able to be provided.
 
Manufacturer Narrative
Investigation conclusion: retained and returned devices from the reported lot number were tested with qc cut-off standards (25 miu/ml) and high-hcg clinical urine samples (205.3-232.6 iu/ml).The results were read at 3 minute 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 either retention or returned product.However, case details indicate that a timer was not used when performing the test.Per the package insert, a timer is required to perform the test.After immersing the test dipstick in the sample, place the test dipstick on a non-absorbent, flat surface, start the timer and wait for the red line(s) to appear.Read the result at 3-4 minutes.Do not interpret the results after the appropriate read time.Per the package insert, false negative results may occur when the levels of hcg are below the sensitivity level of the test.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.Additionally, this test provides a presumptive diagnosis for pregnancy.A confirmed pregnancy diagnosis should only be made by a physician after all clinical and laboratory findings have been evaluated.
 
Event Description
False negative result obtained on (b)(6) 2020 using the consult diagnostics hcg urine dipstick cassette kit.When customer reported issue on (b)(6) 2020, she states patient was evaluated by her physician and she is 7 weeks pregnant currently.This information indicates the patient was 4 weeks pregnant at the time the test was conducted on (b)(6) 2020.On 23 aug 2020, customer provided the following additional information regarding the event: customer unsure exactly how patient was determined to be pregnant, however, believes it was confirmed via ultrasound.Elective liposuction procedure was performed based on the false negative result.Situations in which a patient receives anesthesia following a false negative hcg result will be considered severe as this procedure will likely cause damage but not death to the fetus.Following liposuction procedure, patient is still currently pregnant.
 
Manufacturer Narrative
Additional patient information and event information provided on 23 august 2020: update to b1: event updated to an adverse event and malfunction.Update to b2: other serious or important medical events was selected.Added to section b5: updated information regarding event information and procedure performed based on the false negative result.On 23 aug 2020, customer provided the following additional information regarding the event: customer unsure exactly how patient was determined to be pregnant, however, believes it was confirmed via ultrasound.Elective liposuction procedure was performed based on the false negative result.Situations in which a patient receives anesthesia following a false negative vhcg result will be considered severe as this procedure will likely cause damage but not death to the fetus.Following liposuction procedure, patient is still currently pregnant.Added to section b6: customer states they believe the confirmatory method was an ultrasound, however, they could not be sure.Added depo provera shot to section d10.Update to h1: type of reportable event updated to serious injury mdr.Added to h6: clinical code 4581- appropriate clinical signs, symptoms, conditions term / code not available.Impact code 4610- inadequate/inappropriate treatment or diagnostic exposure component code 3121- test strip.Results pending investigation conclusion.
 
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Brand Name
CONSULT HCG DIPSTICK TEST 5000 25T
Type of Device
PREGNANCY TEST
Manufacturer (Section D)
ALERE SAN DIEGO, INC.
9975 summers ridge road
san diego, ca
MDR Report Key10350588
MDR Text Key201217861
Report Number2027969-2020-00040
Device Sequence Number1
Product Code JHI
UDI-Device Identifier20612479202751
UDI-Public(01)20612479202751(17)201031(10)HCG8110082
Combination Product (y/n)N
PMA/PMN Number
K993203
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup,Followup
Report Date 09/22/2020
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 Expiration Date10/31/2020
Device Model NumberFHC-101
Device Lot NumberHCG8110082
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/06/2020
Initial Date Manufacturer Received 07/21/2020
Initial Date FDA Received07/31/2020
Supplement Dates Manufacturer Received08/23/2020
09/18/2020
Supplement Dates FDA Received09/14/2020
09/22/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
DEPO PROVERA
Patient Outcome(s) Other;
Patient Age38 YR
Patient Weight81
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