MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. SP BRAND RAPID TEST HCG CASSETTE; HCG PREGNANCY TEST

Model Number FHC-102-OBW515

Device Problem False Negative Result (1225)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/25/2014

Event Type  malfunction  

Event Description

Customer reported two (2) potential false negative urine hcg results on one (1) patient, using the sp brand rapid test hcg cassette.The quantitative beta-hcg result was 56,000 miu/ml.The following was reported: -internal control line evident, background clear.-biorad qc performed on each shipment, resulted ok.-kit stored at room temperature.-verified technique: customer stated staff follows package insert (pi).-freshly voided sample.-pouch opened just prior to testing.-urinalysis result turbid (sample not spun or allowed to settle).-age of patient: (b)(6).-lmp: unknown.-renal dysfunction: unknown.-no lot number provided.Sample discarded, unavailable to submit for investigation.There was no reported adverse patient sequela.There was no additional information provided.

Manufacturer Narrative

Lot number: though requested, the lot number was not provided, as customer uses many boxes at a time.Investigation/conclusion: the urine sample was discarded and the lot number was not provided; therefore, further investigation cannot be pursued.

• Brand Name: SP BRAND RAPID TEST HCG CASSETTE
• Type of Device: HCG PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge rd.; san diego CA 92121
• Manufacturer Contact: kelly adams, rn ; 9975 summers ridge rd.; san diego, CA 92121 ; 8588052107
• MDR Report Key: 3938750
• MDR Text Key: 4599346
• Report Number: 2027969-2014-00668
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/02/2014

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 Model Number: FHC-102-OBW515
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/02/2014
• Initial Date FDA Received: 07/16/2014
• 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: VISTARIL; SIEMENS VISTA LABORATORY ANALYZER; ROZEREM; PROZAC
• Patient Age: 27 YR