STACLOT PROTEIN S 0476

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-12-12 for STACLOT PROTEIN S 0476 manufactured by Diagnostica Stago.

Event Text Entries

[21075888] A medical technologist in the coagulation laboratory was comparing lot 953124 with another previously used lot 953076 of the same kit by running both lots in parellel to test a plasma that had been confirmed to be deficient in protein s activity. The test plasma had an expected level of 38% activity; however lot 953124 obtained 54%, whereas the lot 953076 yielded 43%, the latter being much closer to the target value (38%). This overestimation by lot 953124 was not neglibible, and was considered to be due to the test plasma being from a heterozygous pt. In the united states the distributor has not received any report of this nature about lot 953124 as of this date. Invalid data - regarding single use labeling of device. Patient medical status prior to event: unknown. Invalid data - regarding multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. Invalid data - regarding whether event presents imminent hazard. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: a device from same lot was evaluated. Results of evaluation: unanticipated. Conclusion: device was out of spec in a manner that relates to event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device recalled by manufacturer/distributor. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 43429-1995-00001
• MDR Report Key: 31216
• Date Received: 1995-12-12
• Date of Report: 1995-12-07
• Report Date: 1995-12-07
• Date Reported to FDA: 1995-12-07
• Date Added to Maude: 1996-03-14
• Event Key: 0
• Report Source Code: Distributor report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: UNKNOWN
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: STACLOT PROTEIN S
• Generic Name: IN VITRO DIAGNOSTIC TEST KIT/PROTEIN S ACTIVITY IN PLASMA
• Product Code: JGR
• Date Received: 1995-12-12
• Catalog Number: 0476
• Device Expiration Date: 1997-05-01
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: N
• Implant Flag: *
• Device Sequence No: 1
• Device Event Key: 32286
• Manufacturer: DIAGNOSTICA STAGO

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1995-12-12