MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. PROD TEST BRAND; PROD DEVICE TYOE

Model Number M12345

Device Problem Computer Software Problem (1112)

Patient Problem Tricuspid Insufficiency (2111)

Event Date 08/08/2015

Event Type  Injury  

Manufacturer Narrative

Adding text at point of redaction - then redacting.

Event Description

Redacting in prod.

• Brand Name: PROD TEST BRAND
• Type of Device: PROD DEVICE TYOE
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.; 1360 south loop rd.; 1006; alameda CA 94502
• Manufacturer (Section G): ABBOTT DIABETES CARE INC.; 1360 south loop rd.; alameda CA 94502
• Manufacturer Contact: vaibhav pradhan ; 1360 south loop rd.; alameda, CA 94502
• MDR Report Key: 4987491
• MDR Text Key: 22370867
• Report Number: 2954323-2015-11111
• Device Sequence Number: 1
• Product Code: DFD
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K12345678
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,literature,study,use
• Reporter Occupation: Other
• Remedial Action: Recall
• Report Date: 08/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2015
• Device Expiration Date: 01/01/2016
• Device Model Number: M12345
• Device Catalogue Number: C12345
• Device Lot Number: L12345
• Other Device ID Number: O12345
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/01/2015
• Distributor Facility Aware Date: 08/08/2014
• Device Age: 15 YR
• Event Location: Other
• Date Report to Manufacturer: 08/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: CONCOMMITANT PROD MED PRODUCT - PROD REDAC
• Patient Outcome(s): Congenital Anomaly; Life Threatening
• Patient Age: 30 YR
• Patient Weight: 84