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

Model Number 100139

Device Problems Improper or Incorrect Procedure or Method (2017); Incorrect Or Inadequate Test Results (2456); Low Test Results (2458)

Patient Problems Abdominal Pain (1685); Coagulation Disorder (1779); Toxicity (2333)

Event Date 09/10/2015

Event Type  Injury  

Manufacturer Narrative

Investigation is pending.

Event Description

The customer alleged a variance between the inratio inr result and the laboratory inr result.On (b)(6) 2015 at 8:54 am, a patient was tested on the facility's inratio monitor and the inr result was 2.0.Reportedly, multiple drops of blood was applied to the inratio testing strip.This is considered to be an improper technique when performing the inratio test.At 5:00 pm, the patient was hospitalized for coumadin toxicity (laboratory inr=7.2) and abdominal pain (kidney cyst hemorrhage).Treatment included discontinuation of coumadin, normal saline bolus, zofran 4mg iv, morphine 5mg iv, vitamin k 10mg, k-dur 40 meq orally and a normal saline with potassium infusion.The patient recovered and was discharged from the hospital on (b)(6) 2015.There was no additional information provided.

Manufacturer Narrative

Investigation/conclusion: the meter and strips associated with the complaint were returned for investigation.The customer's complaint was not confirmed during in-house testing.Returned and retain strips tested on the returned meter met accuracy criteria.When reviewing in-house testing for lot 369159a, no product deficiency was found.A review of the manufacturing records for lot 369159a did not uncover any non-conformances.The lot meets release specification.The returned meter passed functional and thermistor testing during in-house investigation.Although an improper technique was identified in the complaint, root cause is unable to be determined from the information provided.Based on the information available, there is no indication of a product deficiency.No corrective action is required at this time.

• 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: 5131122
• MDR Text Key: 27673951
• Report Number: 2027969-2015-00829
• 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: health professional
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 09/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100139
• Device Lot Number: 369159A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/07/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: IBUPROFEN 800MG EVERY 8 HOURS ORALLY
• Patient Outcome(s): Hospitalization; Required Intervention