MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TDM CONTROL SET; MULTI-ANALYTE CONTROLS, ALL KINDS (ASSAYED)

Catalog Number 04521536190

Device Problem Difficult to Open or Close (2921)

Patient Problem Injury (2348)

Event Date 03/09/2015

Event Type  Injury  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

A health care professional in a hospital setting alleged an injury while opening a control bottle.The user indicated the bottle was "tough" to open and injured a tendon.According to an occupational physician the user now requires surgery.It was noted that there was no damage on the control bottle which could have caused an injury.It was noted that the user has been performing horseback vaulting exercises for "two decades" which may have preconditioned her for the injury.

Manufacturer Narrative

The customer stated the health care professional may have had a previous injury due to two decades of performing exercises on horseback.This previous injury may have caused or contributed to the health care professional requiring surgery.The control vials are a plastic dropper bottle with a screw on cap.The material is ready to use.There are no special instructions provided or needed to open the vial.The lot number of the control set was 696748 as stated in the medwatch report.The vial involved in the event was discarded.The specific lot number of the vial could not be provided by the customer.The investigation of this event did not confirm the customer's findings.No issues were found with manufacturing practices.Inspection of the lot number in question was performed.All bottles could be opened normally without application of force.It is not likely that the injury occurred due to a tightly capped bottle.

• Brand Name: TDM CONTROL SET
• Type of Device: MULTI-ANALYTE CONTROLS, ALL KINDS (ASSAYED)
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 5108170
• MDR Text Key: 26900281
• Report Number: 1823260-2015-04231
• Device Sequence Number: 1
• Product Code: JJY
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K070200
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Report Date: 10/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 04521536190
• Device Lot Number: 696748
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other