MAUDE Adverse Event Report: LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL OT PING METER GLUCOSE MONITORING SYS/KIT

Device Problem Device Displays Incorrect Message (2591)

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

Event Type  malfunction  

Manufacturer Narrative

Lifescan (lfs) has requested return of the subject product(s) for evaluation. If the product(s) are returned, lfs will evaluate it/them and inform fda of product(s) that do not pass inspection in a supplemental report.

Manufacturer Narrative

Follow-up # 1 (09/19/2013)-device evaluation: the meter involved with this complaint has been returned and evaluated by product analysis (pa) on 9/13/2013 with the following findings: the meter failed testing. The meter was found to have a cracked/broken lcd. If lifescan obtains additional information regarding this complaint, a follow up report will be submitted. At this time, lifescan considers this matter closed.

Event Description

On (b)(6) 2013, the reporter contacted lifescan usa, alleging an unknown issue occured in (b)(6) which was a display issue or a power issue. This complaint is being reported because the reported issue was not resolved with troubleshooting. There was no indication that the product caused or contributed to an adverse event.

• Brand Name: OT PING METER
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL; gubelstrasse 34; zug 6300 ; SZ 6300
• Manufacturer (Section G): LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL; gubelstrasse 34; zug 6300 ; SZ 6300
• Manufacturer Contact: m. chiusano / y. wandolski ; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 3318322
• MDR Text Key: 10921353
• Report Number: 2939301-2013-01468
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082590
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 08/14/2013

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 08/30/2013
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2013
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/14/2013
• Date Manufacturer Received: 08/14/2013
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial