MAUDE Adverse Event Report: TERRAGENE S.A STRYKER SLCD12; AUTO-READER INCUBATOR

Model Number STRYKER SLCD12

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/02/2022

Event Type  malfunction  

Manufacturer Narrative

User informs the incubator is having issues "identifying" the bis and they are giving out false negatives readouts.No further information was provided.Internal review of the dhr did not evidence appearance of false negative readouts in any srbi30 bi batches.Possible malfuction of the auto-reader may generate false-negative results, which may cause the device to fail to perform its essential function and compromise the device's monitoring effectiveness which could cause or contribute to a serious injury.

Event Description

It was reported that the auto reader incubator was not detecting the biological indicators and giving false negative results.

• Brand Name: STRYKER SLCD12
• Type of Device: AUTO-READER INCUBATOR
• Manufacturer (Section D): TERRAGENE S.A; ruta nacional no. 9, km 280; parque industrial micropi; alvear, santa fe 2130 ; AR 2130
• Manufacturer (Section G): TERRAGENE S.A; ruta nacional no. 9, km 280; parque industrial micropi; alvear, santa fe 2130 ; AR 2130
• Manufacturer Contact: hernando carrizo ; ruta nacional no. 9, km 280; parque industrial micropi; alvear, santa fe 2130 ; AR 2130
• MDR Report Key: 18397839
• MDR Text Key: 331383950
• Report Number: 3013145340-2023-00007
• Device Sequence Number: 1
• Product Code: FRC
• UDI-Device Identifier: 07798164678175
• UDI-Public: 07798164678175
• Combination Product (y/n): N
• PMA/PMN Number: K191021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: STRYKER SLCD12
• Device Lot Number: SLCD120821
• Initial Date Manufacturer Received: 02/02/2022
• Initial Date FDA Received: 12/27/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/02/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1