MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. INRATIO PT/INR TEST STRIPS; PROTHROMBIN TIME TEST

Model Number 100071

Device Problems Nonstandard Device (1420); Low Test Results (2458)

Patient Problems Abdominal Pain (1685); Bruise/Contusion (1754)

Event Date 02/19/2015

Event Type  Injury  

Event Description

The caller alleged a discrepant low inratio inr result in comparison to the laboratory inr result.On (b)(6) 2015, the inratio inr was 2.0 which was in the patient's therapeutic range of 2.0 - 3.0.On (b)(6) 2015, the patient noted bruising on his arms and was hospitalized for stomach pain which was not diagnosed.The laboratory inr, at the hospital, was 9.0.Treatment included the administration of vitamin k and holding of coumadin.On (b)(6) 2015, the laboratory inr was 3.6 and the patient was discharged from the hospital in stable condition.On (b)(6) 2015, the inratio inr was 1.6 and the patient was instructed to resume his coumadin on (b)(6) 2015.On (b)(6) 2015, the inratio inr was 3.1.There was no additional information provided.

Manufacturer Narrative

Investigation/conclusion: it is indicated that product is not returning for evaluation.Since the product associated with the complaint was not returned, a review of in-house testing was performed.The retain strip testing results met both accuracy and repeatability criteria.The product performed as expected and no product deficiencies were observed.The manufacturing records for the lot were reviewed and there were issues related to this complaint.Since the monitor was not returned, the impedance curve associated with the discrepant result could not be analyzed for characteristics of a weak-slope change.An impedance curve with a weak-slope change has been identified in (b)(4) to contribute to a potential discrepant result.The root cause is unable to be determined at this time without product return.Further investigation into this issue is being performed under (b)(4).

• Brand Name: INRATIO PT/INR TEST STRIPS
• Type of Device: PROTHROMBIN TIME TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge road; san diego CA 92121
• 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: 4614974
• MDR Text Key: 19348624
• Report Number: 2027969-2015-00198
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Patient Family Member or Friend
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 03/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 100071
• Device Lot Number: 358566
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/04/2015
• 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
• Treatment: COUMADIN; INRATIO MONITOR SN (B)(4)
• Patient Outcome(s): Hospitalization; Required Intervention