MAUDE Adverse Event Report: ROCHE DIAGNOSTICS NH3L2; ENZYMATIC METHOD, AMMONIA

Catalog Number 07236450190

Device Problem High Test Results (2457)

Patient Problem Insufficient Information (4580)

Event Date 09/12/2022

Event Type  Injury  

Manufacturer Narrative

The customer has had no issues with other patient samples.The customer's qc was acceptable.Abnormal aspiration alarms were observed on the customer's alarm trace data.The investigation is ongoing.

Event Description

The initial reporter stated they received questionable results for different samples from one pediatric patient tested with the nh3l2 (ammonia ii) assay on a cobas 8000 c 702 module.The patient is a pediatric patient, born with congenital citrullinemia.The patient was approximately 2 months old at the time of this event and has been admitted to the hospital for approximately half of her life.There have been "a lot" of medication and diet changes implemented during these months.On (b)(6) 2022 at 10:35 the patient was admitted to the hospital due to an elevated s-ammonium.The customer received "repeatedly" high values of ammonia ii which "only partially" match the patient's clinical condition and treatment.Refer to the attached data ("pt-74668") for the specific results.On (b)(6) 2022 the result from the customer's c702 module was 213.6 umol/l.The patient was transferred to a different hospital where the ammonia ii result from a different sample obtained approximately 7 hours later was approximately 50 umol/l on a cobas 8000 c 502 module.At home, the patient is treated with a special diet including oral sodium benzoate and ravicti (glycerol phenylbutyrate).The home treatment was discontinued and a regimen of intravenous (iv) treatment was started.Glucose 10%: 25-35 ml/hour.The acute meds mixture consists of 92 ml glucose (10%), 6.25 ml phenylbutyrate (200 mg/ml), 6.25 ml sodium benzoate, 15 ml arginin hcl ( l-arginine).The glycerol phenylbutyrate infusion (iv) started at about 10:30 am on (b)(6) 2022 with 3 ml/hour (the concentration of phenylbutyrate was approximately 10 mg/ml).The dose was increased to 7 ml/hour at about 7:30 pm (same day).The dose was maintained until (at least) 1 pm on (b)(6) 2022 after which the dose was gradually reduced (after the first blood sampling had been performed at the second hospital).A bolus was given before starting the infusion on (b)(6) 2022 (at approximately 10 am).The bolus was administered over 1 hour and contained 50 ml of the "acute meds" (approximately 500 mg phenylbutyrate).The patient was discharged "a few days" after being transferred to the 2nd hospital.There was no allegation the patient was harmed by the treatment received.The customer suspects a possible drug interference affecting the patient's ammonia ii results.The c702 module serial number was (b)(4).

Manufacturer Narrative

Further information was provided about the patient's general condition and frequency of testing.Additional ammonia ii results were provided.The patient has a permanent iv line.It was noted that small changes (e.G.Infection, changes in diet) can result in high ammonia results.Since on (b)(6) 2022, the patient has been admitted to the hospital between 6-10 times.The patient was admitted to a different hospital on (b)(6) 2022.The patient was admitted to the customer site on (b)(6) 2022 due to a parainfluenza infection.Refer to the attached data for the latest results from the customer site and for additional test results from these hospital admissions.On (b)(6) 2022, the ammonia result at the customer site was 200 umol/l.Following unspecified treatment, the ammonia result was 76 umol/l."later" the ammonia result was again 200 umol/l.

Manufacturer Narrative

The initial report stated: "the initial reporter stated they received questionable results for different samples from one pediatric patient tested with the nh3l2 (ammonia ii) assay on a cobas 8000 c 702 module." this should say: "the initial reporter stated they received questionable results for different samples from one pediatric patient tested with the nh3l2 (ammonia ii) assay on 2 different cobas 8000 c 702 modules."one c702 module serial number was (b)(6).The serial number for the 2nd c702 module was not provided." the initial report stated: "on (b)(6) 2022 at 10:35, the patient was admitted to the hospital due to an elevated s-ammonium." this should say: "on (b)(6) 2022 at 10:25, the patient was admitted to the hospital due to an elevated s-ammonium." the acute meds mixture was supplemented with iv glucose 10% (starting after the bolus).3 ml/hour acute meds + 27 ml/hour glucose 10%.7 ml/hour acute meds + 35 ml/hour glucose 10%.Additionally: at 10:25: 10 ml glucose 10% over 10 minutes (iv bolus).At 10:35: 50 ml isotonic sodium chloride over 15 minutes (iv bolus).The initial report stated: "a bolus was given before starting the infusion on (b)(6) 2022 (at approximately 10 am).The bolus was administered over 1 hour and contained 50 ml of the "acute meds" (approximately 500 mg phenylbutyrate)." this should say: "at 10:50 a bolus was given before starting the infusion on (b)(6) 2022.The bolus was administered over 1 hour (until 11:50) and contained 50 ml of the "acute meds" (approximately 500 mg phenylbutyrate)." additionally: at 10:50: iv treatment of (approximately 31 mg phenylbutyrate/hour) + 27 ml/hour glucose 10% was started at 3 ml/hour.The initial report stated: "the glycerol phenylbutyrate infusion (iv) started at about 10:30 am on (b)(6) 2022 with 3 ml/hour (the concentration of phenylbutyrate was approximately 10 mg/ml).The dose was increased to 7 ml/hour at about 7:30 pm (same day)." this should say: "the glycerol phenylbutyrate infusion (iv) started at about 10:30 am on (b)(6) 2022 with 3 ml/hour (the concentration of phenylbutyrate was approximately 10 mg/ml).The dose was increased to 7 ml/hour between 7:00 p.M.And 7:30 p.M.".

Manufacturer Narrative

Calibration and qc were acceptable.Only samples from 1 patient diagnosed with congenital citrullinemia being treated with phenylbutyrate are affected, therefore, a general reagent issue can be excluded.An interference through icteric, hemolytic, or lipemic sample quality can be excluded.There is no information to suggest a pre-analytical issue.Based on the data received, other medications were excluded as a root cause.Interference testing was performed with phenylbutyrate and associated metabolites.Compared to reference samples (with no medications), no interference with this medication was detected.The investigation did not identify a product problem.The cause of the event could not be determined.

Manufacturer Narrative

Interference testing was performed using reference samples.The following drugs were checked with 2 drug concentrations (therapeutic and toxic concentration) and with 2 ammonia-concentrations in edta-plasma: glycerol phenylbutyrate; phenylbutyrate (na); phenylacetate; phenylacetylglutamine.No drug interference was identified.The results fulfill the claims and all qc was within range.

• Brand Name: NH3L2
• Type of Device: ENZYMATIC METHOD, AMMONIA
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15607896
• MDR Text Key: 301760309
• Report Number: 1823260-2022-03159
• Device Sequence Number: 1
• Product Code: JIF
• UDI-Device Identifier: 04015630936533
• UDI-Public: 04015630936533
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K972250
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: 07236450190
• Device Lot Number: 606449
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2023
• 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
• Patient Sequence Number: 1
• Treatment: FUROSEMID HAMELN; GLUCOSE; PHENOBARBITAL
• Patient Outcome(s): Hospitalization
• Patient Age: 2 MO
• Patient Sex: Male