MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS INTEGRA 800; CLINICAL CHEMISTRY ANALYZER

Model Number I800

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/14/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer complained of water on the reagent side of the cobas integra 800 instrument after receiving an error related to the transfer arm.The customer discovered that a reagent probe was loose and was dripping water on the transfer arm, probes and the reagent area.The customer changed the reagent probe and tried to dry the area.The customer was not able to perform a reagent flow check since the initialization failed.The customer stated that they had issues with approximately 40 patient samples tested for a1cx-2 tina-quant hemoglobin a1cdx gen.2 whole blood application (a1cx-2).The customer provided data for 5 patient samples.Based on the data provided, the a1cx-2 results for 2 patient samples were erroneous when compared to a different integra 800 instrument.None of the erroneous results were reported outside of the laboratory.Patient 1 initial a1cx-2 result from the integra 800 instrument in question was 17.02%.The repeat result from the other integra 800 instrument was 8.49%.Patient 2 initial a1cx-2 result from the integra 800 instrument in question was 21.20%.The repeat result from the other integra 800 instrument was 10.15%.The repeat results from the other integra 800 instrument were believed to be correct.No adverse event occurred.The a1cx-2 reagent lot number was 16445901 with an expiration date of 12/31/2017.The field service engineer (fse) visited the customer site and found that reagent packs were in the incorrect location in the integra 800 instrument.The reagent probes were attempting to go into a 2 bottle reagent pack, but the system assumed a 3 bottle reagent pack as in place causing the reagent probes to break and cause a fish hook due to the reagent probe trying to go into the middle position where there was no bottle since the reagent pack was in the incorrect location.The fse advised the customer to remove all the reagent packs with liquid on them and replaced reagent packs into the correct locations.The reagent probes were then replaced.A liquid flow check was performed on both the sample and reagent side.The customer performed calibration and quality controls and all results were successful.The system is operational.The investigation determined that the issue found by the fse was the root cause of the event.No abnormal trends were identified during a review of complaints for reagent probes used with this instrument.No similar complaints were identified from this customer site on a similar instrument in the past 12 months.

Manufacturer Narrative

The customer has had no further issues.

• Brand Name: COBAS INTEGRA 800
• Type of Device: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE INSTRUMENT CENTER AG TEGIMENTA; forrenstrasse; na; rotkreuz 6343 ; SZ 6343
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 6767380
• MDR Text Key: 83110845
• Report Number: 1823260-2017-01599
• Device Sequence Number: 0
• Product Code: LCP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K951595
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Medical Technologist
• Type of Report: Initial,Followup
• Report Date: 08/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: I800
• Device Catalogue Number: 28122474001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/14/2017
• Initial Date FDA Received: 08/04/2017
• Supplement Dates Manufacturer Received: 07/14/2017
• Supplement Dates FDA Received: 08/25/2017
• 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