MAUDE Adverse Event Report: PHARMA TECH SOLUTIONS, INC. GENULTIMATE!; BLOOD GLUCOSE TEST STRIPS

Catalog Number 100-50

Device Problem High Readings (2459)

Patient Problem Not Applicable (3189)

Event Date 04/09/2018

Event Type  malfunction  

Event Description

A customer complaint prompted an investigation by our company into potential product malfunction.We ran 10 control tests on the customer's product using one touch ultra control solution and a one touch ultra 2 meter.We then calculated the mean of those results and found them to be out of range.We then had retains from the same lot of product tested by a 3rd-party (initial reporter) at a low glucose level and a high glucose level.The strip readings were compared to the glucose levels, which were measured using a ysi 2300 stat plus glucose analyzer.By this method, it was determined that the retain sample product was giving falsely high results at both the low and high glucose levels.

• Brand Name: GENULTIMATE!
• Type of Device: BLOOD GLUCOSE TEST STRIPS
• Manufacturer (Section D): PHARMA TECH SOLUTIONS, INC.; 2660 townsgate rd. ste. 300; westlake village CA 91361
• Manufacturer (Section G): CONDUCTIVE TECHNOLOGIES, INC.; 935 borom rd; york PA 17404
• Manufacturer Contact: keith berman ; 2660 townsgate rd. ste. 300; westlake village, CA 91361 ; 8054461973
• MDR Report Key: 9372443
• MDR Text Key: 210689555
• Report Number: 3008282042-2019-00005
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00868906000100
• UDI-Public: 00868906000100
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103542
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 11/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/18/2019
• Device Catalogue Number: 100-50
• Device Lot Number: AF091
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2016
• 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