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U.S. Department of Health and Human Services

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

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DRES. FREILINGER & PARTNER INRATIO PT/INR STRIPS PROTHROMBIN TIME TEST Back to Search Results
Model Number 99008G1
Device Problems Low Test Results; Device Displays Incorrect Message
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.

 
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Brand NameINRATIO PT/INR STRIPS
Type of DevicePROTHROMBIN 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 Key5645657
Report Number2027969-2016-00306
Device Sequence Number1
Product CodeGJS
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 Received05/10/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator OTHER
Device MODEL Number99008G1
Device LOT NumberK383465
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/13/2016
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 Unkown
Removal/Correction NumberZ-0880, 0881, 0882-2015

Patient TREATMENT DATA
Date Received: 05/10/2016 Patient Sequence Number: 1
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