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

Catalog Number	100-50
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	04/09/2018
Type of Reportable Event	Malfunction
Event or Problem 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!
• Common Device Name: BLOOD GLUCOSE TEST STRIPS
• Manufacturer (Section D): PHARMA TECH SOLUTIONS, INC.; 2660 townsgate rd. ste. 300; westlake village CA 91361
• MDR Report Key: 9372443
• Report Number: 3008282042-2019-00005
• Device Sequence Number: 2325597
• Product Code: NBW
• UDI-Device Identifier: 00868906000100
• UDI-Public: 00868906000100
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K103542
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 11/22/2019

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
• Operator of Device: Other
• Device Expiration Date: 08/18/2019
• Device Catalogue Number: 100-50
• Device Lot Number: AF091
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/09/2018
• Initial Report FDA Received Date: 11/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1