MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COAGUCHEK ® XS SYSTEM; PROTHROMBIN TIME TEST STRIPS

Catalog Number 04625374160

Device Problem High Test Results (2457)

Patient Problem Gastrointestinal Hemorrhage (4476)

Event Date 06/20/2022

Event Type  Injury  

Manufacturer Narrative

The test strips are no longer available for investigation.The meter was requested for investigation and has not been received at this time.If the product is returned in the future, a follow-up report will be submitted.  on a regular basis, coaguchek strips of lots currently valid in the market are tested as part of routine retention testing and the results have passed the internal inspection.  per product labeling: "coaguchek method uses human recombinant thromboplastin.Therefore, the comparability to tests using other human recombinant thromboplastins is best, whereas higher deviations can occur with other thromboplastin types.However, those higher differences between thromboplastins of different (rabbit, bovine) origin are not an issue specific for coaguchek assays.Similar differences can be observed when a human recombinant thromboplastin-based laboratory method is compared with several other (rabbit, bovine) laboratory methods."  occupation: patient/consumer.

Event Description

We received an allegation of questionable inr results for one patient tested with the coaguchekxs meter with serial number (b)(4) compared to an unknown laboratory method and that the meter may have contributed to the patient's two alleged bleeding events.The reporter initially called due to concerns regarding the meter results.On (b)(6) 2022 at around 8:00 am, the meter result was reportedly 5.7 inr.The repeat meter result at 8:37 am was reportedly 5.7 inr.The laboratory result within four hours of the meter result was reportedly 3.4 inr.The results were reported to the doctor.The laboratory result was reportedly deemed correct.The therapeutic range was reported to be 2.0 to 3.0 inr.During the call, the patient mentioned two alleged gastrointestinal (gi) bleeding events: first alleged gi bleeding event - the event reportedly happened in (b)(6) 2022.Further information regarding the bleeding event was requested but not provided as the patient stated that she was not feeling well.The patient declined to provide any further information.Second alleged gi bleeding event - the patient stated that in mid-(b)(6), she threw up two pints of blood.The patient further stated that she was released from the hospital on (b)(6) 2022 due to this event.Further information regarding the bleeding event was requested but not provided as the patient stated that she was not feeling well.The patient declined to provide any further information.There is no information provided about the root cause of the bleeding events.

• Brand Name: COAGUCHEK ® XS SYSTEM
• Type of Device: PROTHROMBIN TIME TEST STRIPS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15411058
• MDR Text Key: 299776843
• Report Number: 1823260-2022-02814
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 00365702127104
• UDI-Public: 00365702127104
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 04625374160
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/15/2022
• Initial Date FDA Received: 09/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: WARFARIN
• Patient Outcome(s): Hospitalization; Other
• Patient Sex: Female