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

Catalog Number 04625374160

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Confusion/ Disorientation (2553)

Event Date 08/25/2022

Event Type  Injury  

Event Description

We received an allegation that the coaguchek meter with serial number: (b)(4) may have contributed to a patient's stroke.The patient initially called due to concerns with the meter accuracy when the meter and laboratory results were compared.During the call, the patient stated that he had a stroke on (b)(6) 2022 and that the doctors advised him that it may have been due to his inr being too low.On (b)(6) 2022 at 7:23 (it is unknown if this result is am or pm), the meter result from the meter memory as reported by the patient was 1.7 inr.The patient stated that the stroke occurred on (b)(6) 2022 at around 12:00 pm while he was eating lunch at work.The patient stated that he broke out into a cold sweat and became confused and disoriented so his coworker drove him to an urgent care center where an echocardiogram (ekg) was reportedly performed.The patient stated that he will not be able to provide the result of the ekg.The urgent care facility staff reportedly advised that he needed to go to the hospital immediately so the patient was reportedly transported to the hospital by ambulance.The patient stated that he had a computed tomography (ct) scan of the brain and that they reportedly found a clot in the front left portion of the brain.The patient also stated that he underwent a magnetic resonance imaging (mri) of the head and stated that he could not provide the findings of this diagnostic test.The patient stated that the laboratory result from a venous draw on (b)(6) 2022 using an unknown laboratory method was 1.44 inr.The patient stated that he was treated with a "clot buster" but could not provide the exact name of the treatment.The patient further stated that the doctor took him off warfarin for two days.He further stated that after two days, he was given an intravenous (iv) drip of heparin for several days but stated that he could not provide the dosage.The patient stated that during the last couple of days in the hospital, he was bridging with the heparin drip and warfarin but could not provide the dosage.The patient stated that he was in the hospital from (b)(6) 2022 until (b)(6) 2022 and that he believes he was in the intensive care unit (icu) for 2 days.On (b)(6) 2022 at 8:01 am, the initial meter result was 5.1 inr.The repeat meter result at 8:04 am was 4.9 inr.The patient stated that he used the same finger in the repeat test.The laboratory result using an unknown laboratory method was 3.6 inr.The patient stated that the laboratory test was performed within 4 hours of meter testing.On (b)(6) 2022 at 7:12 am, the meter result was 3.7 inr.The repeat meter result at 8:04 am was 4.9 inr.The laboratory result using an unknown laboratory method was 2.8 inr.The patient stated that the laboratory test was performed within 4 hours of meter testing.The therapeutic range prior to the patient's stroke was reported to be 1.5-2.0 inr.The testing frequency prior to the patient's stroke was reported to be every two weeks.The therapeutic range after the patient's stroke was reported to be 2.5-3.0 inr.The testing frequency after the patient's stroke was reported to be weekly.The lot number of the test strips the patient used after the stroke is 60124921 with an expiration date of 31-oct-2023.This mdr is being submitted with an abundance of caution.

Manufacturer Narrative

The test strips the patient used at the time of the stroke are no longer available for return.The meter and the test strips used after the patient's stroke were requested for investigation and have 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."  the patient used the same finger when he retested on the meter on (b)(6) 2022.Product labeling states "if you need to redo a test, use a new lancet, a new test strip, and a different finger." occupation: patient/consumer.

• 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: 15690276
• MDR Text Key: 302573686
• Report Number: 1823260-2022-03396
• 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: 10/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2022
• 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, 60124921
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/29/2022
• 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
• Patient Outcome(s): Other; Life Threatening; Hospitalization
• Patient Age: 41 YR
• Patient Sex: Male