MAUDE Adverse Event Report: MED LAB DIAGNOSTICS MED LAB DIAGNOSTICS PH TEST STRIPS; DYE-INDICATOR, PH (URINARY, NON-QUANTITATIVE)

Catalog Number ASIN: B06XG6MYXD

Device Problems Product Quality Problem (1506); Defective Component (2292)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/10/2018

Event Type  malfunction  

Event Description

I was trying to use the brand of med lab diagnostics ph test strips (company name and brand name is one and the same), bought from (b)(6) (asin:(b)(4)), and noticed the quality was not only questionable, but is not nearly as accurate as a ph meter.The product was defective.Upon doing some research, this product is manufactured in (b)(6) and travels all the way to the usa to be sold on (b)(6).My concern is that med lab diagnostics: is selling this ph test strip as an otc product without a u.S.Fda 510(k) clearance.I searched the fda website and could not find their 510(k) clearance.; is not listed on the fda website as an initial distributer/importer of this product (or any of their products for that matter); does not have a registered udi number with the u.S.Fda for this product, or any products sold on (b)(6).I am not sure this product needs a udi number, but still, i could not find one still the same; is promoting this product as if it has fda approval by having the fda icon on its packaging (both box and bottle label); is promoting their company as having registered with the fda on its (b)(6 )listing page, but again, i could not verify this info.I am asking you to verify this information about med lab diagnostics not having an otc authorization with a u.S.Fda 510(k) clearance to sell this product on (b)(6).The quality of this product would indicate it does not have a 510(k).Additionally, i am requesting you verify that med lab diagnostics has not registered with the fda as an initial distributor or importer or having a udi number (if need be)-- for this product, or any of their products under their company and brand name of med lab diagnostics.Lastly, i am asking you to verify if this company has the permission of the u.S.Fda to have your fda icon on their packaging.If these concerns are sustained, i do ask you take appropriate action against this company on (b)(6) ((b)(6) is listing and facilitating the sale of med lab diagnostics ph test strips) and all other marketplaces.My concern is, given a consumer's osteoporosis condition (among other medical conditions that one can gauge via a ph test strip), urine ph values on this test strip might be misrepresented.I feel the consumer should know this is a cheap (b)(6) -made product being sold to unsuspecting consumers who might make medical decisions based on these med lab diagnostics ph test strips.I have screenshots of their (b)(6) listing re: the fda icon if need be, as well as their claim to have been registered with the fda as of 12-13-2012.Thank you.(b)(6).

• Brand Name: MED LAB DIAGNOSTICS PH TEST STRIPS
• Type of Device: DYE-INDICATOR, PH (URINARY, NON-QUANTITATIVE)
• Manufacturer (Section D): MED LAB DIAGNOSTICS; 1968 s. coast hwy #551; laguna beach CA 92651
• MDR Report Key: 8175169
• MDR Text Key: 130983535
• Report Number: MW5082207
• Device Sequence Number: 1
• Product Code: CEN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/13/2018

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/11/2020
• Device Catalogue Number: ASIN: B06XG6MYXD
• Device Lot Number: 2018101201
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/17/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 57 YR
• Patient Weight: 91