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

Catalog Number 04625374160

Device Problem Low Test Results (2458)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 04/22/2021

Event Type  Injury  

Manufacturer Narrative

The patient¿s meter and test strips have been requested for return.The product has not been received at this time.The investigation is ongoing.Routine retention testing was performed.Test strip retention samples passed the internal inspection.Per product labeling, "coaguchek uses human recombinant thromboplastin.Therefore, the comparability to other human recombinant thromboplastins is best, whereas higher deviations can occur with other thromboplastins.However, those higher differences between thromboplastins of different (rabbit, bovine based) origin are not a coaguchek specific issue.Similar differences can be observed when a human recombinant thromboplastin-based laboratory method is compared against several other (rabbit, bovine-based) laboratory methods." medical assessment of the events found hypervascular tumors present higher risk for spontaneous bleeding and bleedings are common side effects in patients under anticoagulation.Occupation was lay user/patient.Unique identifier (udi) # (b)(4).

Event Description

There was an allegation of questionable results from coaguchek xs meter serial number (b)(4).On (b)(6) 2021 at 11:13 pm, the meter result was 3.4 inr.The patient went to the hospital as he thought the result was not correct.The laboratory result less than four hours later using an unknown reagent was 4.5 inr.The hospital detected "blood vessels had opened", stemming from the patient's type of cancer.The type of cancer was requested but was not provided.The patient was treated by applying a topical coagulant to stop the bleed.The patient was not admitted and was released several hours later.The patient's coumadin dosage was not changed.On (b)(6) 2021 at 11:57 am, the meter result was 3.4 inr.The patient believed the meter result did not match his bleeding symptoms and he took himself to the hospital where he was admitted.The laboratory result less than four hours later using an unknown reagent was 4.7 inr.The hospital tried using a topical anticoagulant to stop the bleeding as they had prior, but that was not successful.The patient was then taken into surgery to cauterize the open blood vessels.The patient was placed on heparin to bridge back to coumadin and placed in the intensive care unit until he was released.The patient was released after a few days once his inr was down to 3.2 inr per laboratory testing.The therapeutic range was 3.0-3.5 inr and the patient tests every 1-2 weeks.The patient was currently "feeling ok".

Manufacturer Narrative

No product was received for investigation.If the product is returned in the future, a follow-up report will be submitted.

• Brand Name: COAGUCHEK XS SYSTEM
• Type of Device: PROTHROMBIN TIME TEST STRIPS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 11946295
• MDR Text Key: 254521732
• Report Number: 1823260-2021-01670
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 07/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: 04625374160
• Device Lot Number: 49682021
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COUMADIN; COUMADIN
• Patient Outcome(s): Hospitalization
• Patient Age: 46 YR
• Patient Weight: 77