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 12/16/2019

Event Type  malfunction  

Event Description

A customer complaint prompted an investigation by our company into potential product malfunction.We had the customer's 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 customer's 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): THE BIO CO., LTD.; 2202, #27 sampung-ro; gyeongsanbuk-do, 38543 ; KS 38543
• Manufacturer Contact: keith berman ; 2660 townsgate rd. ste. 300; westlake village, CA 91361 ; 8054461973
• MDR Report Key: 9491956
• MDR Text Key: 210690433
• Report Number: 3008282042-2019-00009
• 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: 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/07/2021
• Device Catalogue Number: 100-50
• Device Lot Number: 9010A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/16/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2019
• 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