MAUDE Adverse Event Report: OK BIOTECH CO., LTD. UNISTRIP1; BLOOD GLUCOSE TEST STRIPS

Model Number 24850

Device Problems Nonstandard Device (1420); Device Markings/Labelling Problem (2911)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Other  

Event Description

Unistrip1 test strips, (b)(4) strips per vial/box, total quantity (b)(4) vial/boxes were shipped to (b)(4), usa at the date/shipment departure date (b)(4) 2014.The shipment contained product that was labeled with the following statement on the box, "for use with one touch ultra, one touch ultra 2, one touch ultramini and one touch ultrasmart meters purchased before 2014".The date "2014" was an error that should have read "2012" that resulted in a correction by mfr to have shipment sent back to (b)(6) on (b)(4) 2014.The returned shipment included(b)(4) vials/boxes resulting in (b)(4) boxes (1 unit was damaged) remaining in distribution in united states.On (b)(4) 2014, during an on-site fda inspection of the mfr, the fda inspectors advises the manufacturer to initiate a recall because a correction or removal conducted to reduce a risk to health posed by a device was not reported in writing to the fda prior to the inspection.On (b)(4) 2014, the importer, (b)(4) had a teleconference with us fda district office and sent the recall info to fda.The lot number and quantity to be recalled: u14030713 ((b)(4) units), u14031313 ((b)(4) units), u14031323 ((b)(4) units), u14031413 ((b)(4) units).

Manufacturer Narrative

The lot number and quantity to be recalled: u14030713 ((b)(4) units), u14031313 ((b)(4) units), u14031323 ((b)(4) units), u14031413 ((b)(4) units).

• Brand Name: UNISTRIP1
• Type of Device: BLOOD GLUCOSE TEST STRIPS
• Manufacturer (Section D): OK BIOTECH CO., LTD.; hsinchu ; TW
• Manufacturer Contact: joanna wang ; no 91, sec 2, gongdao 5th rd; hsinchu 300 ; TW 300 ; 35160258
• MDR Report Key: 4310002
• MDR Text Key: 5212834
• Report Number: 3005862821-2014-00036
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K113135
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 11/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/01/2016
• Device Model Number: 24850
• Device Catalogue Number: 24850
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/16/2014
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention