MAUDE Adverse Event Report: TECAN SCHWEIZ INSTRUMENT GENESIS RSP 150/8; PIPETTING STATION FOR CLINICAL USE

Catalog Number 10039466

Device Problems Fracture (1260); Material Integrity Problem (2978)

Patient Problem Distress (2329)

Event Date 01/14/2014

Event Type  malfunction  

Event Description

The incident happened in the (b)(6) on (b)(6) 2014.A false (b)(6) result for (b)(6) screening test was detected.The pt (pregnant women on routine antenatal clinic) was recalled for a second sample.Second sample of the same pt tested (b)(6).Re-test of first sample remained (b)(6).Lab initiated an investigation that included a recall of 12 pregnant women for redraw for (b)(6) test.Genetic "fingerprint" of genomic dna of both samples shows that they are from the same pt or from identical twins, indicating that first (false (b)(6)) sample was probably contaminated.The incident did not lead to death or serious deterioration in the hlth of a pt or user.Investigations completed by the customer excluded blood sample collection error or labelling error and concluded that instrument genesis rsp 150/8 might have contributed to the contamination of first sample.Genesis rsp 150/8 is used to separate serum and plasma from primary samples into microtube deep well plates and into racks for (b)(6) viral load testing.A complaint was reported to tecan for service on (b)(6) 2014 to evaluate the instrument as part of the investigation and confirm that the instrument was operating as expected.A cracked syringe was detected.Additionally, the lab confirmed that daily maintenance was not being performed.A report was made to (b)(6) upon completion of investigation on (b)(4) 2014 by the lab based on pt distress and tecan was informed.The report concluded that the instrument could not be confirmed as the sole cause of the incident.No other incidents of cross contamination were found during the investigation.

Manufacturer Narrative

Tecan svc engineer checked the genesis rsp 150/8 and observed increased volume of air in dilutor syringe and tubing on (b)(4) 2014.A hairline crack on the back of the glass syringe was found.This crack may have caused air in the sys, which may lead to a drip, contaminating the primary tube with serum from another (b)(6) sample.The syringe was replaced and iq/oq completed on instrument on request from the customer.All results passed.The lab indicated daily maintenance was not performed for this instrument.The operator's manual includes instructions for verification and daily maintenance specifying checks for the syringes and air in the sys.If daily maintenance was done, air in the sys would have been detected.Tecan reviewed the service history for the instrument.A pm was completed (b)(4) 2013 and all syringes were replaced as a requirement of the pm interval.No other service notes regarding problems found during pm and instrument passed all testing.Tecan cannot conclude if the cracked syringe was the root cause or contributed to the event.Tecan has discontinued mfg of this platform in 2004 and service support in 2011.

• Brand Name: INSTRUMENT GENESIS RSP 150/8
• Type of Device: PIPETTING STATION FOR CLINICAL USE
• Manufacturer (Section D): TECAN SCHWEIZ; maennedorf zuerich ; SZ
• Manufacturer Contact: seestrasse 103; maennedorf zuerich 8708 ; 49228560
• MDR Report Key: 3960020
• MDR Text Key: 4626559
• Report Number: 3003402518-2014-00003
• Device Sequence Number: 1
• Product Code: JQW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10039466
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2001
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other