ANTI IGG -RABBIT- * MTS 4024

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-12-07 for ANTI IGG -RABBIT- * MTS 4024 manufactured by Micro Typing Systems, Inc..

Event Text Entries

[17374849] Inconsistent test results with three different lots.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1033952
• MDR Report Key: 562481
• Date Received: 2004-12-07
• Date of Report: 2004-12-07
• Date Added to Maude: 2005-01-03
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: ANTI IGG -RABBIT-
• Generic Name: ANTI HUMAN GLOBULIN ANTI - IGG -RABBIT- MTS ANTI-IGG CARD
• Product Code: KSO
• Date Received: 2004-12-07
• Returned To Mfg: 2004-12-02
• Model Number: *
• Catalog Number: MTS 4024
• Lot Number: 071304001-02
• ID Number: *
• Device Expiration Date: 2005-05-10
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 552200
• Manufacturer: MICRO TYPING SYSTEMS, INC.
• Manufacturer Address: * POMPANO BEACH FL 33069 US

Device Sequence Number: 2

• Brand Name: ANTI IGG - RABBIT-
• Generic Name: ANTI HUMAN GLOBULIN ANTI- IGG -RABBIT- MTS ANTI-IGG CARD
• Product Code: KSO
• Date Received: 2004-12-07
• Returned To Mfg: 2004-12-02
• Model Number: *
• Catalog Number: *
• Lot Number: 071304001-25
• ID Number: *
• Device Expiration Date: 2004-06-13
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 552201
• Manufacturer: MICRO TYPING SYSTEMS, INC.
• Manufacturer Address: * POMPANO BEAH FL 33069 US

Device Sequence Number: 3

• Brand Name: ANTI IGG - RABBIT-
• Generic Name: ANTI HUMAN GLOBULIN ANTI- IGG -RABBIT- MTS ANTI-IGG CARD
• Product Code: KSO
• Date Received: 2004-12-07
• Returned To Mfg: 2004-12-02
• Model Number: *
• Catalog Number: *
• Lot Number: 071304001-26
• ID Number: *
• Device Expiration Date: 2004-06-14
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 3
• Device Event Key: 552203
• Manufacturer: MICRO TYPING SYSTEMS, INC.
• Manufacturer Address: * POMPANO BEACH FL 33069 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2004-12-07