MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COAGUCHEK INRANGE; PROTHROMBIN TIME MONITOR

Catalog Number 07404379016

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/26/2023

Event Type  malfunction  

Manufacturer Narrative

The strip lot number and expiration date were requested but were not provided.The meter and strips have been requested for return.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." per product labeling: anti-phospholipid antibodies (apa) like lupus antibodies (la) may cause falsely prolong coagulation times.(false-high inr values /false-low %quick values).Where apa are known to be present or suspected, testing with the coaguchek has to be discontinued until discussed with the patient´s physician.E3 - occupation was patient/consumer.

Event Description

There was an allegation of questionable results from the coaguchek inrange meter.The result from the meter was 6 or 7 inr.The result from an unknown point of care (poc) device was 3 inr.The result from a laboratory using an unknown reagent was 2.8 inr.The therapeutic range was 2.5-3.5 inr.

• Brand Name: COAGUCHEK INRANGE
• Type of Device: 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 17938753
• MDR Text Key: 325718942
• Report Number: 1823260-2023-03303
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): Y
• Reporter Country Code: AU
• PMA/PMN Number: K170960
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/16/2023

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: 07404379016
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/26/2023
• Initial Date FDA Received: 10/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1