MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS CLINITEST HCG PREGNANCY TEST

Device Problem False Negative Result (1225)

Patient Problem Pregnancy (3193)

Event Date 09/08/2014

Event Type  malfunction  

Event Description

Customer reported false negative human chorionic gonadotropin (hcg) result on the instrument.Customer also reported that patient was (b)(6) months pregnant.There was no report of injury due to this event.

Manufacturer Narrative

Based on the returned patient sample, siemens technical operation team indicated that returned patient urine sample was appeared dark and bloody, with mucous, highly viscous and cloudy after allowing thawing at room temperature.Moreover, patient urine also contained heavy solid sediments and had a strong odor.Siemens technical operation team tested eighteen (18) replicates using customer returned patient urine and customer returned cassettes.Moreover they also tested additional 6 replicates using pooled clear non pregnant male urine and returned customer cassette hcg lot #040038.Siemens technical operation team indicated that during customer returned urine and cassette testing, flow issues and reagent membrane blockages were observed due to high viscosity of urine.Uv light analysis of cassettes with flow issues showed urine flow was greatly impacted at the sample absorbent pad area.Both negative and positive results were obtained from testing lot #040038 with patient urine sample.Whereas, testing performed using same customer returned cassettes with non-pregnant male urine gave accurate negative results.Furthermore, results from serum testing showed patient urine contained 1,468,264.00 miu/ml of hcg.As per clinitest hcg pregnancy test ifu, "high-dose hook effect - high-dose hook effects are not seen with this product until the urine hcg level exceeds 600,000 miu/ml, a level two to three times higher than the highest level seen for pregnant individuals.".

• Brand Name: CLINITEST HCG PREGNANCY TEST
• Type of Device: CLINITEST HCG PREGNANCY TEST
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING, LTD.; northern road; chilton industrial estate; sudbury CO10 2XQ; UK CO10 2XQ
• Manufacturer Contact: steven andberg ; 2 edgewater drive; norwood, MA 02062 ; 7812693655
• MDR Report Key: 4148846
• MDR Text Key: 4910370
• Report Number: 1217157-2014-00149
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032563
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Patient Sequence Number: 1