MAUDE Adverse Event Report: SEKISUI DIAGNOSTICS, LLC 124 OSOM COMBO HCG 25T KIT; HCG TEST

Catalog Number 124

Device Problem False Negative Result (1225)

Patient Problems Ectopic Pregnancy (1819); Pain (1994); Blood Loss (2597)

Event Date 03/05/2014

Event Type  malfunction  

Event Description

Information was received that patient was seen in the clinic on (b)(6) 2014 and a urine sample tested negative using the osom combo test kit.A kidney x-ray was performed and an ultrasound requested.No hcg confirmatory testing was performed.The patient presented the next day, (b)(6) 2014, in the emergency room complaining of "bleeding and being in pain for 4 days." the patient was diagnosed with a "ruptured ectopic pregnancy." laparoscopic left side salpingectomy was performed to remove 1 fallopian tube.

• Brand Name: 124 OSOM COMBO HCG 25T KIT
• Type of Device: HCG TEST
• Manufacturer (Section D): SEKISUI DIAGNOSTICS, LLC; san diego CA
• Manufacturer (Section G): SEKISUI DIAGNOSTICS, LLC
• Manufacturer Contact: mary henderson, ph.d. ; 5353 wayzata blvd.; minneapolis, MN 55416 ; 9525955580
• MDR Report Key: 3963675
• MDR Text Key: 4611620
• Report Number: 2030538-2014-00001
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2015
• Device Catalogue Number: 124
• Device Lot Number: 131519
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2014
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other