MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COAGUCHEK XS PT TEST 1X24 STRIPS; PROTHROMBIN TIME MONITOR

Catalog Number	07797826160
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was requested for investigation.The test strip retention samples passed the internal inspection and complies with specifications.The investigation is ongoing.
Event or Problem Description
We received an allegation that the coaguchek xs pt test 1x24 strips box and bottle expiration dates, and the test strip box and the code on the test strip do not match.The reporter stated that the box's expiration date is 31-jul-2025, and the bottle's is 30-apr-2025; the test strip code on the box is 138, and the code on the test strip is 117.The reporter did not use the test strips.
Additional Manufacturer Narrative
The investigation noted that test strip lot number 75620718 has a manufacturing date of feb-2024, with a code key of s_146; test strip lot number 73986215 has a manufacturing date of nov-2023, with a code key of s_138; and test strip lot number 678099 has a manufacturing date of jan-2023, with a code key of s_117 and an expiration date of jul-2024.The investigation determined that a package mix-up is extremely unlikely, as the manufacturing dates of the two lots are more than two months apart.The investigation did not identify a product problem.

• Brand Name: COAGUCHEK XS PT TEST 1X24 STRIPS
• Common Device Name: PROTHROMBIN TIME MONITOR
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 22307149
• Report Number: 1823260-2025-01912
• Device Sequence Number: 8705552
• Product Code: GJS
• UDI-Device Identifier: 04015630946471
• UDI-Public: 04015630946471
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K060978
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2025
• Device Catalogue Number: 07797826160
• Device Lot Number: 75620718
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/29/2025
• Supplement Date Received by Manufacturer: 07/03/2025
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown