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

Model Number 100071

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems High Blood Pressure/ Hypertension (1908); Transient Ischemic Attack (2109)

Event Date 12/02/2014

Event Type  Injury  

Event Description

The caller alleged discrepant high inratio inr result in comparison to the laboratory inr result.On (b)(6) 2014 in the morning, the patient tested on her inratio and received a 2.1.Additionally, the patient reported improper techniques; testing while monitor was on her lap and adding multiple drops of blood.Approximately eight (8) hours later, the patient was hospitalized with a transient ischemic attack (tia).The laboratory inr was 1.6.The patients therapeutic range was 2.0-3.0.The patient was incorrectly given warfarin 2.5mg instead of the warfarin dose that she was originally taking (3.75mg).On (b)(6) 2014, the laboratory inr was 1.73.The medication error was identified and she was administered warfarin 6mg and lovenox injections twice daily.On (b)(6) 2014, the inratio inr was 2.1 and the laboratory inr was 1.7.During the hospitalization, the patient was started on hydralazine and norvasc for hypertension.On (b)(6) 2014, the patient was discharged from the hospital and was reported as "doing fine." there was no additional information provided.

Manufacturer Narrative

Investigation pending.

Manufacturer Narrative

Investigation/conclusion: the product associated with the complaint was returned for investigation.The complaint was not confirmed during in-house investigation.Investigation of the returned monitor using retain strips did not uncover any deficiencies.The monitor and strips continue to meet specification and no product deficiencies were observed.Customer reported complaint on lot 350587.However at the time of the investigation, retains for this lot were no longer available.As a result lot 350588 was selected.The manufacturing records for the lot were reviewed.The lot met specifications and no non-conformances were documented.Improper techniques were identified in the complaint.These cannot be ruled out as a possible root cause for the unexpected results.The customer has antiphospholipid syndrome(aps).Testing with an aps-insensitive laboratory method is recommended for these patients.The customer's blood sample may have interfered with the coagulation test and may have contributed to the unexpected results.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 rd.; san diego CA 92121
• Manufacturer Contact: ya-ling king ; 9975 summers ridge rd.; san diego, CA 92121 ; 8588052084
• MDR Report Key: 4388222
• MDR Text Key: 5309725
• Report Number: 2027969-2015-00002
• 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: Consumer,Distributor
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 12/09/2014

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: 100071
• Device Lot Number: 350587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/15/2015
• Initial Date FDA Received: 01/06/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/21/2015
• Was Device Evaluated by Manufacturer?: No
• 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: INRATIO MONITOR - SN 101600200; LEVEMIR; INVOKANA 300MG; METFORMIN 500MG; VENLAFAXINE ER 225MG; PRAMIPEXOLE .075; UNSPECIFIED ANTIBIOTIC; LANSOPRAZOLE 30MG; FENOFIBRATE 145MG; DILTIAZEM 120MG; METOPROLOL 25MG
• Patient Outcome(s): Hospitalization