MAUDE Adverse Event Report: UNKNOWN GI MAP TEST DIAGNOSTIC SOLUTIONS LABORATORY; LABORATORY DEVELOPED TEST

Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	Distress (2329)
Date of Event	02/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
I am reporting a potentially inaccurate and misleading result from a gi map test conducted by (b)(6) laboratory.I took the gastrointestinal microbial assay plus (gi-map) test on (b)(6) 2025, and it returned a positive result for helicobacter pylori (h.Pylori) this led to significant emotional distress and potential risk of aggressive, unnecessary treatment.However, i underwent an endoscopy on (b)(6) 2025, where repeat testing showed helicobacter pylori (h.Pylori) was not present.I contacted the lab on (b)(6) and followed their protocol, including having my physician submit documentation of the negative result.Despite this, the lab refused a refund and has not acknowledged their test's inaccuracy.I also received a second bill on (b)(6) for (b)(6) that ignored my initial (b)(6) payment.I believe this test may be providing false positives and is not clinically reliable.I am requesting fda investigation into this test's accuracy and whether it meets proper diagnostic validation standards.Sincerely, (b)(6).The test was positive, but the endoscopy confirmed this was a false positive.The positive test caused undue stress and additional medical testing.

• Brand Name: GI MAP TEST DIAGNOSTIC SOLUTIONS LABORATORY
• Common Device Name: LABORATORY DEVELOPED TEST
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 21995021
• Report Number: MW5170185
• Device Sequence Number: 16962181
• Product Code: OQS
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 05/03/2025

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
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/09/2025
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FISH OIL.; IRON.; MULTI VITAMIN.; VITAMIN D.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 33 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White