MAUDE Adverse Event Report: DRES. FREILINGER & PARTNER INRATIO PT/INR STRIPS; PROTHROMBIN TIME TEST

Model Number 99008G1

Device Problems Low Test Results (2458); Device Displays Incorrect Message (2591)

Patient Problem Skin Discoloration (2074)

Event Date 04/13/2016

Event Type  Injury  

Manufacturer Narrative

Investigation pending.

Event Description

A report of discrepant inratio results was received on (b)(6) 2016.Results as follows: (b)(6).Caller reports that the patient had various error codes from the beginning; the specific error codes are unknown.The patient went to their physician's office on (b)(6) 2016 with various bruises.The lab result on (b)(6) 2016 was 6.5; the patient was given vitamin k.

Manufacturer Narrative

It is indicated that the product is not returning for evaluation.Therefore, a review of the entire in-house testing history was performed.In-house testing on strip lot k383465 meets release criteria.The product performed as expected.A review of the manufacturing records for the lot did not uncover any non-conformances.The lot met release specifications.It was reported that the customer has rheumatic diseases.These conditions may impact the performance of the assay.Root cause cannot be determined from the information provided.Capa-(b)(4) was initiated to investigate highly discrepant results.

• Brand Name: INRATIO PT/INR STRIPS
• Type of Device: PROTHROMBIN TIME TEST
• Manufacturer (Section D): DRES. FREILINGER & PARTNER; pfaffenhofener str. 5; au in der hallertau; 84072 ; GM 84072
• Manufacturer (Section G): ALERE SAN DIEGO, INC.; 9975 summers ridge road; san diego CA 92121
• Manufacturer Contact: ya-ling king ; 9975 summers ridge road; san diego, CA 92121 ; 8588052084
• MDR Report Key: 5645657
• MDR Text Key: 44888800
• Report Number: 2027969-2016-00306
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K110212
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 99008G1
• Device Lot Number: K383465
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-0880, 0881, 0882-2015
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention