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

Catalog Number 04625315003

Device Problems High Test Results (2457); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Thrombosis/Thrombus (4440); Insufficient Information (4580)

Event Date 02/27/2023

Event Type  Injury  

Manufacturer Narrative

The strip code and lot that were allegedly used by the patient were the incorrect strips for the coaguchek inrange meter.Per product labeling, the strips being used by the patient are only for use with a coaguchek xs, coaguchek xs plus, and the coaguchek pro meter.The patient had been diagnosed with anti-phospholipid antibodies (lupus anticoagulant).Per us product labeling: the presence of anti-phospholipid antibodies (apas) such as lupus antibodies (la) may lead to prolonged clotting times, i.E., they may cause false-high inr values.If you have or suspect that you have apas, discontinue testing until you discuss with your physician.Initial reporter occupation is patient/consumer.The meter and strips were requested for investigation.Replacement product was sent.The product 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 results have 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.

Event Description

The initial reporter alleged a discrepancy in results from coaguchek inrange meter serial number: (b)(4) compared to a laboratory result for 1 patient.The patient was reportedly diagnosed with venous thrombosis.On (b)(6), 2023 at 6:30 p.M., the meter result was reportedly 3.1 inr.On (b)(6), 2023 at 6:47 p.M., the meter result was reportedly 2.7 inr.On (b)(6), 2023, the patient was allegedly diagnosed with venous thrombosis.The patient allegedly was experiencing severe pain in their legs and had received thrombosis stockings and thrombosis injections as treatment.The patent was currently in rehab.On (b)(6), 2023 at 7:25 p.M., the patient reportedly had a meter result of 2.8 inr.At the same time, a venous blood sample was collected from the patient and the laboratory result using an unknown method, was reportedly 2.1 inr.The patient's therapeutic range is reportedly 2.5-3.0 inr and the patient tests daily.

• Brand Name: COAGUCHEK XS PT TEST
• 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: 16657136
• MDR Text Key: 312444794
• Report Number: 1823260-2023-01028
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K170960
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: 04625315003
• Device Lot Number: 6281811
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/02/2023
• 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: MARCUMAR.
• Patient Outcome(s): Other