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

Model Number 100139

Device Problems Nonstandard Device (1420); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Complaint, Ill-Defined (2331); Lethargy (2560)

Event Date 04/27/2014

Event Type  Injury  

Event Description

Caller alleged discrepant low inratio inr result in comparison to the laboratory inr result.On (b)(6) 2014, laboratory inr was 13.0 and coumadin was held.(b)(6) 2014, laboratory inr was 13.1 and the patient was seen in the emergency room and administered vitamin k.On (b)(6) 2014, inratio inr was 1.4 and the laboratory inr was 11.0; coumadin was held.The time between testing was within five (5) minutes.The same day, the patient was hospitalized due to lethargy and general degeneration of condition.As of (b)(6) 2014, the patient remained hospitalized.Though requested, no additional information was provided.

Manufacturer Narrative

Investigation pending.

• Brand Name: INRATIO PT/INR TEST STRIPS
• Type of Device: PROTHROMBIN TIME TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; san diego CA
• Manufacturer Contact: ya-ling king ; 9975 summers ridge rd; san diego, CA 92121 ; 8588052084
• MDR Report Key: 3862849
• MDR Text Key: 4459629
• Report Number: 2027969-2014-00479
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 04/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100139
• Device Lot Number: 340804
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/28/2014
• Initial Date FDA Received: 05/22/2014
• 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-1564-2014
• Patient Sequence Number: 1
• Treatment: BACTRIM; ASPIRIN 81MG DAILY; VITAMIN D3; CRESTOR; DIAGOXIN; DILTIAZEM HYDROCHLORIDE; SENNA; TRAMADOL; CALCIUM; INRATIO MONITOR, SN: (B)(4).; COUMADIN; TYLENOL 325MG 3X/WEEK; CYMBALTA; CIPRO
• Patient Outcome(s): Hospitalization; Required Intervention